Archived medical countermeasure-related news from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi) and federal partners. Also see our events archive.
Visit MCMi News and Events for current happenings.
- September 22, 2016: From NIH - Experimental Zika Virus DNA Vaccines Protective in Monkeys
September 21, 2016: In response to CDC's request to amend the Trioplex Real-time RT-PCR Assay issued on March 17, 2016, FDA granted the CDC-requested amendments, including claims for detecting Zika virus, Dengue virus, and chikungunya virus RNAs in whole blood (EDTA) specimens. Additional technical information, including updated Instructions for Use and fact sheets
September 21, 2016: From HHS - HHS forges strategic partnerships with two global companies to develop new antibiotics
September 20, 2016: From the Pan American Health Organization - PAHO creates new Health Emergencies Program
September 19, 2016: From HHS Secretary Sylvia Matthews Burwell - Making Progress on Combating Antibiotic Resistance
September 19, 2016: CDC updates guidance for Wynwood (FL) neighborhood with active Zika transmission
September 19, 2016: FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and New Biological Therapeutics from October 2007 to December 2015. Comments received on this list will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development in the future. Comment by November 18, 2016.
September 18, 2016: PrecisionFDA has launched the PrecisionFDA App-a-thon in a Box - help build the PrecisionFDA app library, which enables the community to explore, access, and try next-generation sequencing apps - more info: video (4:11)
September 16, 2016: HHS has issued a new regulation (final rule) and the National Institutes of Health (NIH) has issued a new policy to increase the availability of information about clinical trials via ClinicalTrials.gov. Regulations are effective as of January 18, 2017. (Federal Register notice) - also see: HHS takes steps to provide more information about clinical trials to the public (NIH press release) - video (3:20) featuring Dr. Francis Collins, NIH
September 16, 2016: NIST Releases New 'Family' of Standardized Genomes - Scientists expand set of tools for accurate DNA sequencing
September 15, 2016: Working to develop better, faster zika tests by Dr. Nicole Lurie, HHS ASPR
September 15, 2016: FDA Consumer Update - Cutting-Edge Technology Sheds Light on Antibiotic Resistance
September 15, 2016: From HHS/ASPR - Why some emerging infectious diseases cause epidemics
September 14, 2016: CDC is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. The interim final rule is effective on October 14, 2016; submit comments by November 14, 2016. (Federal Register notice)
September 13, 2016: From NIH Research Matters - Finding compounds that inhibit Zika
September 9, 2016: From CDC - National Preparedness Month: Radiation Emergencies
September 9, 2016: On November 17-18, 2016, FDA will hold a public advisory committee meeting of the Blood Products Advisory Committee in Silver Spring, MD. On November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States. (Federal Register notice)
September 8, 2016: From NIH, Federal prize competition seeks innovative ideas to combat antimicrobial resistance - The Antimicrobial Resistance Diagnostic Challenge will award $20 million in prizes over all phases of the competition for new, innovative and novel laboratory diagnostic tests. The diagnostic tests being sought are those that identify and characterize antibiotic resistant bacteria and those that distinguish between viral and bacterial infections to reduce unnecessary uses of antibiotics, a major cause of drug resistance. The prize is sponsored by the National Institutes of Health (NIH) and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) in support of the National Action Plan for Combating Antibiotic Resistant Bacteria (PDF, 442 KB). Concepts must be submitted by January 9, 2017, for the first phase of the competition. (Federal Register notice)
September 8, 2016: From HHS - HHS awards $350,000 to American Academy of Pediatrics to help children affected by the Zika Virus
September 7, 2016: On September 1-2, 2016, FDA participated in a meeting with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan) to discuss regulatory approaches for the evaluation of antibacterial agents. The EMA, PMDA, and FDA consider that a robust response to the problem of antimicrobial resistance must be multi-faceted and that the regulatory approach for the evaluation of antibacterial agents is only one element of the total response that is required to encourage and accelerate new antibacterial drug development to meet patient needs. View the meeting summary (PDF, 34 KB)
September 7, 2016: From HHS - HHS accelerates development of mRNA-based Zika vaccine
September 6, 2016: From HHS - In One Month: Our Work Protecting Americans from the Zika Virus
September 6, 2016: MCMi email update - Tips to help you get ready for emergencies | Research update for N95 Day | Zika EUA | September events - subscribe - take our email survey
September 2, 2016: FDA issues final rule on safety and effectiveness of antibacterial soaps - Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes (Federal Register notice) - also see the Consumer Update: FDA Taking Closer Look at 'Antibacterial' Soap
August 29, 2016: From NIH - NIH collaboration helps advance potential Zika treatments
August 26, 2016: FDA issued an EUA for emergency use of Roche Molecular Systems, Inc.'s LightMix® Zika rRT-PCR Test for the qualitative detection of RNA from Zika virus in human serum and EDTA plasma. Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, approximately 7 days following onset of symptoms, if present. Positive results are indicative of current infection. Also see Zika Emergency Use Authorization information - Additional technical information
August 26, 2016: MCMi email update - FDA advises testing for Zika virus in all donated blood in the U.S. - subscribe - take our email survey
August 26, 2016: As a further safety measure against the emerging Zika virus outbreak, FDA issued a revised guidance recommending universal testing of donated whole blood and blood components for Zika virus in the U.S. and its territories. The revised guidance replaces earlier guidance issued in February and March of this year. Guidance for Industry: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components (PDF, 279 KB) - also see Safety of the Blood Supply
August 23, 2016: From NIH - Vaccines protect monkeys against Zika infection
August 22, 2016: FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury - The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.
August 19, 2016: From CDC - Additional area of active Zika transmission identified in Miami Beach - Miami-Dade County residents and visitors advised to take steps to reduce risk of Zika transmission - also see Advice for people living in or traveling to South Florida
August 18, 2016: MCMi email update - Zika diagnostic update | New cross-species immune system reference (open access!) - subscribe - take our email survey
August 17, 2016: FDA issued an EUA for emergency use of InBios International, Inc.’s ZIKV Detect™ IgM Capture ELISA for the presumptive detection of Zika virus IgM antibodies in human sera. This is the first commercially available serological test for Zika available under EUA (the first serological test, the CDC Zika MAC-ELISA, was initially authorized for use in February 2016). Also see Zika Emergency Use Authorization information - Additional technical information
August 17, 2016: From the HHS blog - A Simple Way You Can Help Us Fight the Zika Virus
August 16, 2016: In an MCMi Regulatory Science project, Stanford University researchers used mass cytometry to conduct the first single-cell comprehensive cross-species analyses of immune system function. The data from these studies may help identify new biomarkers of disease and interpret in vitro, nonclinical and clinical studies performed to support the identification and development of countermeasures against chemical, biological, radiological, and nuclear (CBRN) agents, and emerging infectious diseases. The data, including analysis tools to evaluate results, are now available to the research community through a free, open-access website. To request access to the antibody screening and cross-species datasets, please contact Zach Bjornson at firstname.lastname@example.org.
August 15, 2016: Notice of Proposed Rulemaking, from CDC - CDC is amending its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments are being proposed to aid public health responses to outbreaks of communicable diseases such as the largest recorded outbreak of Ebola virus disease (Ebola) in history, the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and repeated outbreaks and responses to measles in the United States, as well as the ongoing threat of other new or re-emerging communicable diseases. Comment by October 14, 2016.
August 12, 2016: HHS declares a public health emergency in Puerto Rico in response to Zika outbreak - Coordinating with the government of Puerto Rico to help combat the virus, which puts thousands of pregnant women at risk
August 10, 2016: USAID Announces Initial Results of Grand Challenge to Combat Zika - USAID invests over $15 million to accelerate development and deployment of 21 innovations to combat the spread of Zika
- August 8, 2016: NIAID RFA - Elucidation of Mechanisms of Radiation-Induced Endovascular Injury and Development of Treatments/Mitigators for Radiation-Induced Endothelial Cell and Vascular Dysfunction - submit letters of intent by October 10, 2016
August 5, 2016: FDA Voice - FDA Working to Keep the U.S. Blood Supply Safe from Emerging Threats, by Peter Marks, MD, PhD and Luciana Borio, MD
August 5, 2016: FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito - FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, FDA has published a final environmental assessment (EA) (PDF, 3 MB) and finding of no significant impact (FONSI) (PDF, 198 KB) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment. Also see Genetically Engineered Mosquitoes
August 4, 2016: FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Luminex Corporation’s xMAP® MultiFLEX™ Zika RNA Assay for the qualitative detection of RNA from Zika virus in human serum, plasma, and urine. Also see Zika Emergency Use Authorization information - Additional technical information
- August 3, 2016: FDA approves first generic version of widely used influenza drug, Tamiflu - FDA approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older.
- August 3, 2016: NIH begins testing investigational Zika vaccine in humans - also see Q&A: Phase 1 Clinical Trial of the NIAID Zika Virus Investigational DNA Vaccine
- August 2, 2016: Consumer Update: FDA researchers advance science for vaccines to prevent mumps and whooping cough
- August 2, 2016: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Submit interest or nominations by September 1, 2016.
- August 2, 2016: From CDC - Safe travels for Zika and other dangerous samples - CDC manages the permit process for researchers to bring samples of Zika virus safely from other countries into the U.S. for studies
- August 1, 2016: HHS awards $5.1 million to InBios to advance Zika diagnostic - A blood test that may reduce from days to hours the time needed to diagnose patients with recent Zika virus infections will receive advanced development support from the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).
- August 1, 2016: From CDC - Advice for people living in or traveling to Wynwood, a neighborhood in Miami, FL, where Zika is being spread by mosquitoes - also see CDC issues travel guidance related to Miami neighborhood with active Zika spread
- August 1, 2016: From HHS - Single-dose anthrax vaccine enters clinical trial with HHS support
- July 29, 2016: From NIH - Zika infection is caused by one virus serotype, NIH study finds - finding may have implications for vaccine development
- July 29, 2016: MCMi email update - FDA Zika Emergency Use Authorizations and blood collection advice | New fluoroquinolone antibiotics warnings - subscribe - let us know how we can make this newsletter more useful for you: take our survey
July 29, 2016: FDA issued an Emergency Use Authorization (EUA) to authorize emergency use of Siemens Healthcare Diagnostics Inc.’s VERSANT® Zika RNA 1.0 Assay (kPCR) Kit for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine. Also see Zika Emergency Use Authorization information - Additional technical information
July 29, 2016: From CDC - Florida investigation links four recent Zika cases to local mosquito-borne virus transmission
July 28, 2016: Statement from Peter Marks, MD, PhD, Director, FDA’s Center for Biologics Evaluation and Research on the July 27, 2016 advice to blood collection establishments on non-travel related cases of Zika virus in Florida
- July 28, 2016: HHS forges unprecedented partnership to combat antimicrobial resistance - CARB-X was created to help address the threat of antibiotic resistance and it is one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.
- July 27, 2016: FDA advice to blood collection establishments on non-travel related cases of Zika virus in Florida (Note: this advice was updated August 4, 2016 to remove Broward County) - also see Safety of the Blood Supply on our Zika virus response page, and a statement from Peter Marks, MD, PhD, Director, FDA’s Center for Biologics Evaluation and Research
- July 27, 2016: NIAID-supported research in mice has unveiled important structural details in the interaction between a key Zika virus protein and Zika antibodies. The information on the antibody-virus interaction could aid vaccine design efforts. In further experiments, the scientists used two newly identified Zika antibodies as a prophylactic treatment to prevent mice from becoming infected by Zika.
- July 26, 2016: FDA updates warnings for fluoroquinolone antibiotics - limits use for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections
- July 25, 2016: From CDC - Using the Law to Prepare for Global Health Emergencies
- July 25, 2016: CDC Issues Updated Zika Recommendations: Interim Guidance for healthcare providers caring for pregnant women with possible exposure to Zika virus; Interim Guidance for the prevention of sexually transmitted Zika virus
- July 25, 2016: Health-research sector small businesses invited to learn about NIH funding at national conference November 15-17, 2016 (Orlando, FL) - Small businesses seeking to commercialize health-related technologies in the medical or life science sector can learn how to access more than $870 million in federal funding during the Department of Health and Human Services Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) conference - registration and more info
- July 19, 2016: FDA issued an Emergency Use Authorization (EUA) to authorize emergency use of Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR Test (Viracor-IBT) for the qualitative detection of RNA from Zika virus in human serum, plasma or urine. Also see Zika Emergency Use Authorization information
- July 18, 2016: From FDA Voice: The Rise in Orphan Drug Designations: Meeting the Growing Demand - also see Designating an Orphan Product: Drugs and Biological Products
- July 12, 2016: MCMi email update - FDA takes action against Zika virus | HHS Zika diagnostics summit | FDA Grand Rounds on 3D printing + more events - subscribe - let us know how we can make this newsletter more useful for you: take our survey
July 12, 2016: FDA Takes Action against Zika virus - learn more about FDA's Zika response efforts in this FDA Voice blog post by FDA Commissioner Robert M. Califf, MD, and Acting Chief Scientist Luciana Borio, MD
July 7, 2016: CDC Releases Detailed History of the 2014-2016 Ebola Response in MMWR - Also see: Overview, Control Strategies, and Lessons Learned in the CDC Response to the 2014–2016 Ebola Epidemic and MMWR Supplements: Current Volume (65)
July 5, 2016: From CDC - Global Health Security: How is the U.S. doing?
July 5, 2016: From NIH - NIH funds Zika virus study involving U.S. Olympic team - Researchers will monitor potential infections among group of U.S. athletes traveling to Brazil
July 5, 2016: From NIH - PREVAIL treatment trial for men with persistent Ebola viral RNA in semen opens in Liberia
June 30, 2016: CDC and USDA released the first Select Agent Program Annual Report - see also: Safeguarding Deadly Pathogens and Poisons (blog post from CDC), and a CDC infographic about select agents (PDF, 1.2 MB)
June 30, 2016: FDA released its fifth progress report highlighting its recent actions to promote the judicious use of antimicrobials in food-producing animals - more about judicious use of antimicrobials
June 29, 2016: From NIH - Analysis of 1976 Ebola outbreak holds lessons relevant today
June 29, 2016: From CDC - New study sheds light on how some survive Ebola: Finding points way to new approaches to Ebola treatment
June 29, 2016: FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens - FDA cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S.
June 28, 2016: The National Academies of Science - Health and Medicine Division released a workshop summary report: The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile
June 26, 2016: In response to CDC's request to amend the CDC Zika MAC-ELISA EUA, FDA reissued the February 26, 2016, EUA in its entirety with the CDC-requested amendments incorporated. The amendments (PDF, 494 KB): (1) update the language for the CDC Zika virus clinical and epidemiological criteria; (2) update the language related to additional testing of positive or equivocal test results using the CDC algorithm; (3) allow use of Zika COS-1 Recombinant Antigen (CDC catalog #AV0005) as Zika Viral Antigen in addition to Lyophilized Zika Vero E6 Tissue Culture Antigen (CDC catalog #AV002 or AV003); and (4) as described in Section IV. More
June 24, 2016: HHS moves to boost Zika vaccine capacity in Brazil - International effort aims to prevent infections from Zika and other emerging diseases
June 23, 2016: FDA: A Great Place for Science ... and for Scientists on the New Frontier of Regulatory Science - FDA Voice blog post by Robert Califf, MD
June 21, 2016: CBER Laboratories in the Life Sciences-Biodefense Complex - FDA Voice blog post by Carolyn Wilson, PhD
June 21, 2016: NIH launches large study of pregnant women in areas affected by Zika virus - International effort to enroll approximately 10,000 women - also see Q&A on the Zika in Infants and Pregnancy (ZIP) Study
June 20, 2016: HHS advances pathogen reduction technologies for blood products - Products may reduce risk of emerging infectious diseases, including Zika, in the blood supply
June 17, 2016: FDA issued an Emergency Use Authorization (EUA) to authorize emergency use of Hologic, Inc.’s Aptima Zika Virus assay, a test to help detect Zika virus infection in people who have symptoms of Zika virus infection, and live in or have traveled to an area with active Zika virus transmission. This test is intended for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Additional technical information
June 15, 2016: MCMi email update - Zika reference materials for diagnostic manufacturers + better understanding Ebola's after-effects to help find new treatments - subscribe
June 15, 2016: To help Zika diagnostic manufacturers assess traceability of their tests (a requirement for Emergency Use Authorization), FDA has created the FDA Zika Virus Reference Materials for NAT-based IVD devices, available upon request to Zika device developers who have a pre-EUA submission with the agency and have established the analytical and clinical performance of their assay. View an infographic about the FDA Zika Virus Reference Materials (PDF, 120 KB)
June 13, 2016: The Centers for Medicare and Medicaid Services (CMS) proposed new standards to advance healthcare quality and equity in our nation’s hospitals. In a proposed rule open for public comment, CMS recommends strengthening Conditions of Participation related to infection prevention and antibiotic prescribing in U.S. hospitals and critical-access hospitals. The rule includes provisions for preventing healthcare-associated infections, stopping spread of antibiotic-resistant germs and reducing inappropriate antibiotic prescribing. Submit comments by August 15, 2016.
June 10, 2016: FDA approves vaccine to prevent cholera for travelers
June 10, 2016: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Submit notice of interest for selection, or nomination materials for prospective candidates by July 11, 2016.
June 8, 2016: ASPR TRACIE released an updated version of Zika: Resources at Your Fingertips (PDF, 724 KB) to reflect updated resources and new information. ASPR's At Risk, Behavioral Health, and Community Resilience program also released Promoting Stress Management for Pregnant Women during the Zika Virus Disease Outbreak: A Resource for Healthcare Providers, and planning resources to enhance healthcare coalition and healthcare system preparedness and response to a domestic Zika virus disease outbreak.
June 7, 2016: From the ASPR Blog - Anticipating Threats, Investing in Solutions - "Deadly new strain of bacteria? BARDA's already working on it."
June 7, 2016: In May 2016, BARDA, CDC, NIH, and FDA signed a Memorandum of Understanding for development of innovative technologies to identify antimicrobial-resistant bacteria. This agreement provides a framework for coordination and collaborative efforts to spur innovation in the development of diagnostic devices that would be of great clinical and public health utility in combating the development and spread of bacteria that are resistant to antimicrobial drugs.
June 7, 2016: In April 2016, NIH, the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS), and FDA signed a Memorandum of Understanding to set forth a framework for reciprocal cooperation which will assist each agency in meeting its responsibilities in promoting proper laboratory animal care and welfare. Implementation of this agreement is intended to maintain and enhance agency effectiveness while avoiding duplication of efforts to achieve required standards for the care and use of laboratory animals.
June 7, 2016: CDC is soliciting nominations for membership on the Clinical Laboratory Improvement Advisory Committee (CLIAC) and requesting suggested topics to be considered for future Committee deliberation. Nomination materials due August 1, 2016.
June 6, 2016: The Department of Homeland Security (DHS) is seeking to advance development of a fabric technology to provide real-time initial decontamination after exposure to chemicals. Apply by July 1, 2016.
June 2, 2016: Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form (Form FDA 3926, PDF, 88 KB) also see Expanded Access to Investigational Drugs for Treatment Use Q&A (PDF, 180 KB) and Charging for Investigational Drugs Under an IND Q&A (PDF, 87 KB) - more about Expanded Access
May 31, 2016: FEMA published the 2016 National Preparedness Report, which identifies cross-cutting findings that evaluate core capability performance, key findings in the Prevention, Protection, Mitigation, Response, and Recovery mission areas, and notable examples of preparedness progress over the past five years
- May 31, 2016: DoD is seeking information from biologics manufacturers with advanced, adaptable vaccine manufacturing platforms with the goal of identifying one or more developers whose platform(s) are amenable to targeting known antigens for use as a prophylaxis. Respond by June 30, 2016.
May 31, 2016: From CDC MMWR - Interim Guidance for Interpretation of Zika Virus Antibody Test Results
May 26, 2016: From HHS - Proactive Efforts by U.S. Federal Agencies Enable Early Detection of New Antibiotic Resistance
May 26, 2016: FDA issues final food defense regulation - FDA today finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply. More about the final rule
- May 26, 2016: FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Idylla™ Ebola Virus Triage Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the Idylla™ Instrument System (Idylla™ System) in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. Additional technical information
May 25, 2016: From CDC - New Guide Developed to Help U.S. Hospitals Improve Antibiotic Use; A National Health Priority
May 23, 2016: The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) is requesting information from the general public and stakeholders related to efforts and strategies to combat antibiotic-resistance. Submit responses by June 22, 2016.
May 19, 2016: FDA has awarded a BAA contract to Stanford University to analyze Ebola survivors with and without chronic health problems in an effort to identify factors responsible for driving prolonged disease well after the initial, acute infection. This research will help the global scientific community better understand the course of Ebola virus infection—an important factor in finding new treatments. More about MCMi BAA awards, including additional Ebola-related projects
May 18, 2016: CDC expanding groundbreaking disease identification tool - MicrobeNet allows better and quicker germ identification and health response
May 16, 2016: The public comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes closed on May 13, 2016. FDA is thoroughly reviewing all public comments and information submitted before determining its next steps. Oxitec will not conduct the field trial of its OX513A mosquito until FDA has had the opportunity to review public comments on the draft EA and determined whether it will finalize the EA and FONSI or prepare an Environmental Impact Statement.
- May 16, 2016: HHS/BARDA has posted a pre-solicitation notice for next-generation anthrax vaccines
May 15, 2016: FDA Expert Q&A: Boosting Diversity in Clinical Trials
May 13, 2016: NIAID has posted an RFP for Preclinical Models of Infectious Diseases - respond by July 13, 2016
May 13, 2016: MCMi email update - Zika response update from FDA: Spanish & Portuguese pages, new EUA - subscribe
- May 13, 2016: FDA issued an EUA to authorize emergency use of the altona Diagnostics GmbH RealStar Zika Virus RT-PCR Kit U.S. to detect Zika virus in the blood of patients who have symptoms of Zika virus infection and live in or have traveled to an area with active Zika virus transmission. This test is intended for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. This is the first commercial Zika diagnostic test that will be available for purchase by labs and will include serum and urine specimens. Additional technical information
May 12, 2016: Zika and Pregnancy: 6 Tips for Staying Healthy, from HHS ASPR
May 10, 2016: From CDC MMWR - Interim Guidance for Zika Virus Testing of Urine
May 10, 2016: HHS-sponsored study shows disrobing is vital decontamination method - Study provides new scientific evidence of best methods to protect people from chemical contamination - also see Decontamination Guidance for Chemical Incidents, from HHS
May 10, 2016: FDA issues rule for data collection of antimicrobial sales and distribution by animal species - Additional data help further target efforts to ensure judicious use of medically important antimicrobials (Federal Register notice) - additional information from FDA's Center for Veterinary Medicine
May 9, 2016: From CDC's Public Health Matters Blog - The Strategic National Stockpile’s Unique Role in Zika Prevention
May 9, 2016: HHS sponsors point-of-care anthrax diagnostic test - Simple, fast finger-prick blood test could aid in medical response to bioterrorism attack
May 2, 2016: Presentations and transcripts are now available from the Filovirus Medical Countermeasures Workshop held at Fort Detrick, MD in October 2015
April 29, 2016: From CDC, The Strategic National Stockpile: Key to Protecting the Nation's Health
April 29, 2016: NIAID has posted a BAA solicitation for advanced development of multivalent vaccine candidates for filovirus and Lassa fever - respond by July 8, 2016
April 29, 2016: MCMi email update - New Zika diagnostic EUA (first commercially available) + Emergency Dispensing Orders for anthrax preparedness - subscribe
- April 28, 2016: FDA issued an EUA to authorize emergency use of Focus Diagnostics, Inc.'s Zika Virus RNA Qualitative Real-Time RT-PCR test to detect Zika virus in the blood of patients who have symptoms of Zika virus infection and live in or have traveled to an area with ongoing Zika virus transmission. This is the first commercial test to detect Zika virus that has been authorized by FDA for emergency use. Additional technical information
- April 27, 2016: HHS helping lift key hurdle in the efforts to develop better Zika diagnostics - To speed the development of diagnostic tests for Zika virus infection, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) will support the collection of blood samples from people in the continental United States and Puerto Rico who have been infected with Zika virus.
- April 26, 2016: HHS awards $5 million to Puerto Rico health centers to fight the spread of Zika virus
- April 26, 2016: The World Health Organization has released a new version of its WHO Zika App for healthcare workers (Android , Apple )
- April 20, 2016: HHS sponsors new broad spectrum antibiotic development - single treatment for multiple common infections and a biothreat enters last stages of development
- April 20, 2016: Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary (from NAS Health & Medicine Division, formerly IOM)
- April 19, 2016: NIH study finds factors that may influence influenza vaccine effectiveness
- April 18, 2016: In this two-part interview, FDA's Dr. Richard Moscicki takes a deep dive into FDA’s Breakthrough Therapy designation to help clarify common misunderstandings around this expedited program.
April 15, 2016: FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies. DuoDote, AtroPen, CANA, Morphine Sulfate, and Pralidoxime Chloride auto-injectors manufactured by Meridian Medical Technologies nearing or beyond their labeled or extended expiration dates should be retained until further guidance is provided by FDA. More about expiration dating extensions
- April 15, 2016: FDA is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). Submit comments by May 16, 2016.
- April 13, 2016: FDA issued two Emergency Dispensing Orders to facilitate anthrax preparedness for stakeholders. FDA issued these orders in collaboration with CDC, which issued Emergency Use Instructions (i.e., fact sheets) for these two products: doxycycline and ciprofloxacin. The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization. More about emergency use of approved MCMs
- April 13, 2016: Presentations, webcast recordings, and resources, and a transcript of the summit press conference are now available from the CDC Zika Action Plan Summit held April 1, 2016
- April 13, 2016: CDC Concludes Zika Causes Microcephaly and Other Birth Defects - Scientists at CDC have concluded, after careful review of existing evidence, that Zika virus is a cause of microcephaly and other severe fetal brain defects. In the report published in the New England Journal of Medicine, the CDC authors describe a rigorous weighing of evidence using established scientific criteria.
April 13, 2016: USAID Announces $30 Million Grand Challenge to Combat Zika and Future Disease Threats - Call for ideas now open; initial focus on improved tools to prevent and respond to Zika. USAID will begin taking Grand Challenge applications on April 29, 2016, with Zika-focused submissions due by 5 p.m. on May 20, 2016 and all other submissions due by 5 p.m. on June 17, 2016.
- April 12, 2016: MCMi email update - Protecting the U.S. from emerging public health threats (report) | New EUA guidance | Zika updates - subscribe
April 12, 2016: FDA published the MCMi Fiscal Year 2015 Program Update for the Medical Countermeasures Initiative's fifth year of operations. FDA continues our ongoing work to advance the development and availability of medical countermeasures (MCMs) to protect against chemical, biological, radiological, and nuclear (CBRN) threats. This report covers these activities including MCM-related regulatory science, and legal and policy actions.
April 11, 2016: The Defense Advanced Research Projects Agency’s Biological Technologies Office (BTO) is hosting a Proposers Day on April 28, 2016 in advance of a planned Broad Agency Announcement (BAA) for the INTERfering and Co-Evolving Prevention and Therapy (INTERCEPT) program.
April 11, 2016: FDA and the Brazilian Health Regulatory Agency (ANVISA ) have issued a joint statement of continued cooperation to address the public health emergency presented by the Zika virus disease outbreak in the Americas - em português
April 7, 2016: In direct response to requests from the public, FDA has extended the comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes. Aedes aegypti mosquitoes are known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya. The comment period will now end on May 13, 2016.
April 7, 2016: FDA posted a grant opportunity - Strengthening Partnerships with State Legislatures to Promote the Safety of FDA Regulated Products and Advance Public Health. Application closing date is July 2, 2016.
- April 6, 2016: Selected presentations are now available from the March 28-29, 2016 workshop Zika Virus in the Americas: An HHS Expert Consultation to Accelerate the Development of Countermeasures, co-sponsored by HHS, NIH, CDC, BARDA, and FDA.
April 6, 2016: CDC issued a BAA for research funding in several areas including antibiotic resistance and public health surveillance. Responses due May 6, 2016.
April 5, 2016: FDA is sharing an interactive tool for mobile health app developers created by the Federal Trade Commission (FTC) in collaboration with the FDA, the Office of the National Coordinator for Health IT (ONC) and HHS’s Office of Civil Rights (OCR). The purpose of the tool is to help developers whose apps collect, create or share consumer information determine which federal laws apply to their products.
April 4, 2016: HHS blog - Zika and Pregnancy: What You Should Know
March 2016: The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) issued Draft Report 1: Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria (PDF, 2.2 MB)
March 30, 2016: MCMi email update - FDA allows use of investigational test to screen blood donations for Zika virus - subscribe
March 30, 2016: FDA allows use of investigational test to screen blood donations for Zika virus - FDA announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. Once screening of blood donations for Zika virus using the investigational test begins, blood establishments in Puerto Rico may resume collecting donations of Whole Blood and blood components.
March 29, 2016: The U.S. Department of State invites comments from the public and relevant industries on influenza surveillance and response, related to the implementation of the World Health Organization (WHO) Pandemic Influenza Preparedness Framework (PIP-FW, PDF, 167 KB). Comment on PIP-FW virus sharing and benefits sharing by April 10, 2016, and PIP-FW governance and linkages by May 25, 2016.
March 29, 2016: NIH posted a funding opportunity, Partnerships for Countermeasures against Select Pathogens. Submit applications by October 3, 2016.
March 29, 2016: NIH posted a Funding Opportunity Announcement to provide an expedited funding mechanism for research on Zika virus and its complications. Applications will be accepted on a rolling basis, beginning on April 20, 2016.
March 28, 2016: The CDC Office of Public Health Preparedness and Response (OPHPR) has posted a Broad Agency Announcement (BAA) open for concept paper submission until April 25, 2016. The aim of this funding is to support innovative research to improve the ability of CDC and its partners, including state and local health departments, emergency management organizations, and health care entities, to effectively prepare for and respond to public health emergencies and disasters.
March 21, 2016: FDA approves new treatment for inhalation anthrax - On March 18, 2016, FDA approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. See also: PHEMCE-supported drug achieves FDA approval
March 18, 2016: FDA and NIH Release a Draft Clinical Trial Protocol Template for Public Comment - comment on the draft template by April 17, 2016
March 18, 2016: MCMi email update - Zika updates from FDA: GE mosquitoes, guidances/Q&A + workshop registration closes today (3/18) - subscribe
March 16, 2016: Experimental dengue vaccine developed by NIH and FDA scientists protects all recipients in virus challenge study (NIH news release)
March 15, 2016: CDC has released Biosafety Guidance for Transportation of Specimens and for Work with Zika Virus in the Laboratory
March 15, 2016: The Invent Health Initiative: Invention and Innovation in Emergency Preparedness, a blog post from the HHS Idea Lab
March 15, 2016: Preparing for Emergencies: A Legal Perspective, from CDC
March 15, 2016: The NIH Countermeasures Against Chemical Threats (CounterACT) program has released two new funding opportunities to support identification and optimization of therapeutics to treat exposures to chemical warfare agents and toxic industrial chemicals: Identification of Therapeutic Lead Compounds and Optimization of Therapeutic Lead Compounds - apply by September 13, 2016 for 2017 start dates
March 15, 2016: NIAID is seeking proposals for advanced development of multivalent vaccines against Ebola virus, Sudan virus, Marburg virus and Lassa fever. See the presolicitation notice and check FedBizOpps.gov for updates.
- March 11, 2016: FDA is releasing for public comment a draft environmental assessment (EA) (PDF, 33 MB) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya. FDA is also releasing a preliminary finding of no significant impact (FONSI) (PDF, 148 KB) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment.(Federal Register notice) Comment by May 13, 2016 (extended deadline). More: Oxitec Mosquito - Also see Investigational Products
March 10, 2016: CDC has posted a grant opportunity for Emerging Infections Sentinel Networks - Infectious Disease Specialists - apply by May 20, 2016
March 10, 2016: FDA is announcing that a proposed collection of information, Guidance: Emergency Use Authorization of Medical Product, has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Fax written comments on the collection of information by April 11, 2016.
- March 10, 2016: CDRH invites medical device industry, academia, and health care facilities to participate in its 2016 Experiential Learning Program, designed to provide medical device review staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. Submit requests to participate by April 11, 2016.
March 10, 2016: FDA is backing long-term improvements to national integrated food safety through a cooperative grant program for State-level Food Protection Rapid Response Teams (RRTs). Submit letters of intent by March 30, 2016.
March 9, 2016: The Presidential Commission for the Study of Bioethical Issues has released a new educational module (PDF, 494 KB) on research design in the context of a public health emergency. The module integrates material from the Bioethics Commission’s report Ethics and Ebola: Public Health Planning and Response.
March 9, 2016: BARDA is seeking a single-dose post-exposure prophylaxis (PEP) anthrax vaccine (Small Business Sources Sought Notice) - respond by noon on March 23, 2016
March 8, 2016: FEMA is accepting applications for its Youth Preparedness Council - submit by March 20, 2016
March 8, 2016: FDA Consumer Update - FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough
March 8, 2016: FDA’s Commissioner’s Fellowship Program is accepting applications for the Class of 2016 from April 1 - May 12, 2016. FDA invites outstanding health care professionals, scientists, and engineers to apply to its two-year fellowship program, where they will receive regulatory science training and the chance to conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior scientist.
March 7, 2016: From CDC's Public Health Matters blog, Planning for Kids: Preparedness and Pediatrics
March 7, 2016: HHS ships blood products to Puerto Rico in response to Zika outbreak (HHS news release) - HHS is arranging and funding shipments of blood products from the continental United States to Puerto Rico to ensure an adequate supply of safe blood for island residents as the Commonwealth of Puerto Rico experiences active mosquito-borne Zika transmission. The first batch of blood products arrived in Puerto Rico on Saturday, March 5. Also see Safety of the Blood Supply
March 4, 2016: FDA authorized emergency use of the OraQuick® Ebola Rapid Antigen Test for the detection of Ebola Zaire virus in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. Also see Emergency Use Authorization below
- March 4, 2016: FDA is seeking comments related to a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE Nonclinical SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of nonclinical study data. FDA is seeking public comment on the use of the PhUSE Nonclinical SDRG template for regulatory submissions.
- March 3, 2016: CDC released its March Vital Signs report focused on protecting patients from healthcare-associated infections (HAIs), including those caused by antibiotic resistant bacteria. CDC also released its new Antibiotic Resistance Patient Safety Atlas, an interactive web app on healthcare-associated infections caused by antibiotic-resistant bacteria. The tool uses data reported to CDC from more than 4,000 healthcare facilities to provide national, regional, and state map views of superbug/drug combinations showing percent resistance over time.
- March 2, 2016: FDA Assistant Commissioner for Counterterrorism Policy and Acting Chief Scientist Dr. Luciana Borio joined other expert witnesses in a hearing on Examining the U.S. Public Health Response to the Zika Virus, House Energy and Commerce Committee, Subcommittee on Oversight and Investigations - read Dr. Borio's testimony
- March 2, 2016: Determination and declaration regarding emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection - more Zika virus EUA information
- March 1, 2016: HHS invites nominations for its new Health Care Industry Cybersecurity Task Force, due by March 9, 2016.
- March 1, 2016: FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue products - As an additional safety measure against the emerging Zika virus outbreak, FDA today issued new guidance (PDF, 78 KB) for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). Also see Safety of the Blood Supply
February 29, 2016: On Rare Disease Day 2016 FDA announced the launch of the Orphan Products Natural History Study Grants Program, funding much-needed natural history studies to facilitate product development for rare diseases. FDA intends to commit approximately $2 million and award 2-5 grants in Fiscal Year 2017 (October 1, 2016-September 30, 2017).
February 29, 2016: A Workshop in Brief summary is available for the February 16, 2016 Institute of Medicine workshop Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus.
February 26, 2016: MCMi email update - Zika response updates from FDA, including an Emergency Use Authorization issued today - subscribe
February 25, 2016: FDA calls on the genomics community to further assess, compare, and improve techniques used in DNA testing by launching the first PrecisionFDA challenge. The challenge is open through April 25, 2016.
February 25, 2016: CDC is seeking nominations for possible membership on the Board of Scientific Counselors, Office of Public Health Preparedness and Response, which consists of 11 experts in the fields associated with public health preparedness and response. Apply by April 15, 2016.
February 24, 2016: FDA Statement on Senate Confirmation of Dr. Robert M. Califf
February 23, 2016: NIAID and West Africa partners announce initial results from Ebola clinical trials: Experimental Ebola Vaccines Well Tolerated, Immunogenic in Phase 2 Study (PREVAIL 1), Experimental Ebola Drug ZMapp May Benefit Patients, but Insufficient Data to be Certain, Study Finds (PREVAIL 2), Ebola Survivor Study Yields Insights on Complications of Disease (PREVAIL 3)
February 23, 2016: FDA BAA funding - Advanced Research and Development of Regulatory Science including medical countermeasure areas of interest - accepting BAA responses until February 22, 2017
February 23, 2016: Meeting videos are available for the February 16, 2016 Institute of Medicine workshop Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus. Presentations are also available, under Other Meeting Resources, on the right side of the videos page.
February 19, 2016: Emergency Preparedness - Keeping Medications Safe (video, 4:01) - FDA Drug Info Rounds pharmacists discuss the importance of being prepared for emergency situations and discuss the resources that pharmacists can rely on when advising their patients.
February 19, 2016: NIH posted a grant funding opportunity - Rapid Assessment of Zika Virus (ZIKV) Complications
February 19, 2016: BARDA released a funding opportunity announcement to establish the Combating Antibiotic Resistance Bacteria (CARB) Biopharmaceutical Accelerator. Interested parties should plan to attend a pre-application workshop on March 3, 2016 from 3:00 – 5:00 p.m. EST at the Hubert H. Humphrey Building, in the Auditorium, located at 200 Independence Ave SW, Washington, DC 20201. More
February 18, 2016: DARPA is seeking ground-breaking single-investigator proposals from junior faculty for research and development in the areas of physical sciences, engineering, materials, mathematics, biology, computing, informatics, and manufacturing of interest to DARPA's Biological Technologies Office (BTO), Defense Sciences Office (DSO) and Microsystems Technology Office (MTO). Apply by April 5, 2016.
February 16, 2016: The Department of Defense (DoD) is seeking participants for the National Chemical and Biological Defense Consortium
February 16, 2016: As a safety measure against the emerging Zika virus outbreak, FDA issued a new guidance (PDF, 111 KB) recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection. Read the news release
February 12, 2016: MCMi email update - New events: Zika research (next week!), BSL-4 data quality training, TBI - subscribe
February 11, 2016: FEMA is accepting grant applications for its Chemical Stockpile Emergency Preparedness Program - apply by April 1, 2016
February 10, 2016: The National Science Foundation is accepting research proposals on Zika that address the ecological transmission dynamics of the virus
- February 12, 2016: FDA announced that influenza virus neuramindase (NA) is available for licensing. This technology may offer an alternative to currently available therapeutic NA inhibitors. Potential commercial applications include: prophylactic and therapeutic against influenza virus infections; diagnostic tests for influenza virus infections; and reagent to measure the potency of H1N1 NA in influenza virus vaccines.
- February 9, 2016: International Coalition of Medicines Regulatory Authorities (ICMRA) statement on Zika virus - The International Coalition of Medicines Regulatory Authorities (ICMRA) has pledged its support to the World Health Organization (WHO) in countering the Zika outbreak. ICMRA brings together 21 medicines regulators from every region in the world, and its members are working together to fight against Zika virus disease, building on ICMRA’s collaborative work on Ebola. Read the full statement
- February 9, 2016: The FDA Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program. Pharmaceutical companies interested in participating in this program may submit proposed agendas to CDER by April 11, 2016.
- February 8, 2016: Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance (full article PDF, 413 KB) - journal article in Public Health Reports - Medical countermeasures (MCMs) are medical products used during public health emergencies. This study, conducted within the Mini-Sentinel Initiative, sought to develop the patient identification and matching processes necessary to assess safety outcomes for MCMs. Abstract only - more about Mini-Sentinel
February 8, 2016: White House fact sheet - Preparing for and Responding to the Zika Virus at Home and Abroad
- February 2, 2016: FDA's Center for Biologics Evaluation and Research (CBER) invites biologics facilities to participate in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. If interested in participating, biologics facilities should contact CBER for more information by March 3, 2016.
February 1, 2016: FDA is working with drug makers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective — with an eye toward avoiding drug shortages. Read more in the FDA Voice blog.
January 28, 2016: FDA and NIH have published BEST glossary (Biomarkers, Endpoints & other Tools), to harmonize terms used in translational science and medical product development. The BEST glossary aims to capture distinctions between biomarkers and clinical assessments and to describe their distinct roles in biomedical research, clinical practice, and medical product development. NIH and FDA intend to use the definitions included in this glossary when communicating on topics related to its contents (e.g., biomarkers) to ensure a consistent use of the terms and therefore, a common understanding of the issues.
January 28, 2016: Zika virus resources: The Zika Virus: What You Need to Know (White House), Zika 101 (HHS/CDC), Zika virus health information resources, including materials in Portuguese and Spanish (NIH/NLM)
January 28, 2016: CDC has published the 2016 National Snapshot of Public Health Preparedness
January 27, 2016: FDA Voice blog - 2016: The Year of Diversity in Clinical Trials - Controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains for FDA is ensuring that research participants are representative of the patients who will use the medical product.
January 26, 2016: FDA needs to know when a serious problem with a medical product is suspected or identified in clinical use. FDA Drug Info Rounds pharmacists discuss how FDA’s MedWatch program makes it easy to get important safety information directly from you to us. (video, 3:15)
January 26, 2016: From the NIH Director's Blog - Zika Virus: An Emerging Health Threat
January 25, 2016: The World Health Organization has released interim guidance on clinical care for survivors of Ebola virus disease
January 24, 2016: CDC has released new information pertaining to the prevention, transmission, symptoms, and management of Zika virus. See also: Pan American Health Organization statement on Zika virus transmission and prevention
January 21, 2016: CDC invites comment on a newly proposed information collection project entitled “Monitoring and Coordinating Personal Protective Equipment (PPE) in Healthcare to Enhance Domestic Preparedness for Ebola Response.” The development of an ongoing Personal Protective Technology (PPT) sentinel surveillance system in the hospital setting will document data used to evaluate and monitor use and effectiveness for PPE usage in healthcare workers including Ebola protection. Comment by March 21, 2016.
January 15, 2016: FDA outlines cybersecurity recommendations for medical device manufacturers - new draft guidance addresses postmarket management of cybersecurity vulnerabilities (also see Guidance and industry information below)
January 14, 2016: A U.S. Food and Drug Administration perspective on evaluating medical products for Ebola (open access journal article in Clinical Trials)
January 14, 2016: WHO news release - Latest Ebola outbreak over in Liberia; West Africa is at zero, but new flare-ups are likely to occur
January 13, 2016: MCMi email update - Will a new drug help, hurt, or do nothing? The power of randomized clinical trials, plus pediatric MCMs, and PHEMCE workshop slides - subscribe
January 13, 2016: Transcripts are now available from the public workshop Clinical Trial Designs for Emerging Infectious Diseases (November 2015)
January 11, 2016 - Will a new drug help, hurt, or do nothing? View a TEDx talk by FDA Acting Chief Scientist Dr. Luciana Borio on the power of randomized clinical trials.
January 7, 2016: FDA presentations from the January 6-7, 2016 PHEMCE Stakeholders Workshop are available:
Industry Partnerships: Linking the scientific and regulatory environments (PDF, 1.6 MB) - includes an MCM regulatory science overview, CBER MCM research and a case study on prolonging anthrax vaccine shelf life, determining MCM dose in special populations (CDER), and a regulatory perspective on infectious disease diagnostics and the FDA-ARGOS database
Beyond The Last Mile: MCM Monitoring and Assessment during Public Health Emergencies - What capabilities do we need? (PDF, 525 KB) - presented by HHS/ASPR and FDA
Monitoring and Assessment: FDA’s Role (PDF, 231 KB)
January 7, 2016: In a three-part FDA Voice blog series, Acting FDA Commissioner Stephen M. Ostroff, MD, looks back at 2015, and ahead to the future. Topics include medical product innovation, medical product safety and oversight (including notes on FDA's Ebola response), and food, tobacco, and antimicrobial resistance.
- January 4, 2016: Students ages 14-23 are encouraged to participate in the HHS/ASPR My Preparedness Story Video Challenge by creating a short video (60 seconds or less) that answers the question, “How are you helping family, friends, and community to protect their health during disasters and every day?” Enter by March 28, 2016.
- January 4, 2016: The National Institute of Allergy and Infectious Diseases (NIAID) has published a Broad Agency Announcement (BAA) solicitation: Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Biomarkers/Devices - NIAID is seeking contract proposals focused on the development of candidate medical countermeasures (MCM) or biodosimetry biomarkers/devices to assess and reduce mortality and/or major morbidities associated with exposure to radiation from a radiological or nuclear incident. Responses are due by March 22, 2016.
December 29, 2015: FDA is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs. Submit comments on the collection of information by January 28, 2016. Related: Clinical Trial Designs in Emerging Infectious Diseases workshop materials
December 28, 2015: View a new web resource from FDA on pediatric medical countermeasures
December 23, 2015: Bioresearch Monitoring Information System (BMIS) Data - To foster transparency and encourage information sharing within the clinical research community, FDA’s Center for Drug Evaluation and Research (CDER) maintains a bioresearch monitoring website that makes clinical research information available to the public. This site contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs and therapeutic biologics. This information is extracted from IND-related documents submitted to FDA and made available to the public as the BMIS database , updated quarterly (most recently updated December 23, 2015). Related: Clinical Investigator Inspection List
December 22, 2015: HHS released the 2015 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP) (PDF, 926 KB) - more about the PHEMCE SIP
December 22, 2015: The White House announced the National Action Plan for Combating Multidrug-Resistant Tuberculosis (MDR-TB) (PDF, 774 KB), a comprehensive set of federal activities and a call to action to the global community to combat the rise of MDR-TB around the globe - fact sheet about this announcement
December 21, 2015: HHS ASPR Blog - Better protecting our nation against future anthrax attacks - related: FDA approves vaccine for use after known or suspected anthrax exposure
December 15, 2015: The Radiation Emergency Medical Management (REMM) website was recently redesigned to make it more user-friendly and have a more modern navigation system. REMM offers health care providers key clinical information about the various types of radiation incidents and injuries, and how to recognize, triage and treat these injuries. It also provides instructional and training material about radiation itself and the federal assets available to help with the response. REMM information also is available through the REMM mobile app for Apple, Android, and Blackberry devices.
December 15, 2015: FDA Launches precisionFDA to Harness the Power of Scientific Collaboration - precisionFDA provides the genomics community with a secure, cloud-based platform where participants can access and share datasets, analysis pipelines, and bioinformatics tools, in order to benchmark their approaches and advance regulatory science. precisionFDA is currently in beta testing.
December 11, 2015: MCMi email update - Wound dressing approved for civilian use | Drug approval case studies | Device cybersecurity workshop - subscribe
December 9, 2015: The HHS Secretary has amended seven Public Readiness and Emergency Preparedness (PREP) Act declarations, continuing PREP Act coverage for pandemic influenza, Ebola virus disease vaccines and therapeutics, anthrax, botulinum toxin, smallpox, and Acute Radiation Syndrome medical countermeasures. Also see PREP Act FAQs.
December 7, 2015: FDA clears military traumatic wound dressing for use in the civilian population - FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only to use in adults and adolescents in the general population.
December 4, 2015: Clinical Framework and Medical Countermeasure Use During an Anthrax Mass-Casualty Incident - updated CDC recommendations and reports
November 24, 2015: FDA approves first seasonal influenza vaccine containing an adjuvant - FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.
November 23, 2015: FDA approves vaccine for use after known or suspected anthrax exposure - FDA approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. BioThrax is the first vaccine to receive approval based on the Animal Rule.
November 18, 2015: MCMi email update - Animal Rule final guidance | EID clinical trials workshop recording | MCM events - subscribe
November 16, 2015: During the G-20 Leaders’ Summit in Antalya, Turkey, President Obama announced that the United States and 30 countries have made a commitment to work together to achieve the targets of the Global Health Security Agenda.
- November 16, 2015: New web page - Medical Product Development Tools at FDA
- November 16, 2015: FDA's Center for Devices and Radiological Health (CDRH) invites medical device industry, academia, and health care facilities to request to participate in the 2015 Experiential Learning Program, a training program for FDA's medical device review staff. Submit requests for participation by December 16, 2015.
- November 16, 2015: November 16-22, 2015 is Get Smart About Antibiotics Week (CDC)
- November 13, 2015: FDA approved a supplemental Biologics License Application (sBLA) for a new indication of use of Neulasta® (pegfilgrastim) for the treatment of adult and pediatric patients at risk of developing myelosuppression after a radiological/nuclear incident - view the revised product label (PDF, 1.7 MB)
- November 12, 2015: From the White House, We’ve Reached a Major Milestone in the Fight Against Ebola
- November 12, 2015: HHS to procure two inhalational anthrax treatments for national supply
- November 10, 2015: CDC has updated the State, Tribal, Local & Territorial Public Health Professionals Gateway, an online portal connecting the public health workforce to information, tools, and resources
- November 6, 2015: FDA Voice - Traveling to the Heartland to Discuss Antimicrobial Resistance
- November 2, 2015: (via NIAID) Small U.S.-based companies developing countermeasures to protect healthy tissue from the effects of radiation exposures may be eligible for a unique funding opportunity offered through the National Space Biomedical Research Institute (NSBRI). NSBRI's Industry Forum is soliciting applications for its Space Medical and Related Technologies Commercialization Assistance Program (SMARTCAP ). SMARTCAP grants are used to accelerate the development of products meeting a need on Earth as well as in space. Applications are due November 30, 2015.
- October 29, 2015: From the White House, A National Biosafety and Biosecurity System in the United States
- October 23, 2015: The FBI and CDC have issued the 2015 Joint Criminal and Epidemiological Investigations Handbook (PDF, 4.8 MB)
- October 23, 2015: Funding opportunity - NIAID is soliciting responses for administrative and management services support to rapidly establish clinical research collaborations with government, academia and health researchers in response to urgent research demands. Responses are due December 7, 2015.
- October 21, 2015: Funding opportunities - BARDA is accepting BAA responses for the Advanced Research and Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures, Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases, and Advanced Development of Medical Countermeasures for Pandemic Influenza - closing date for applications is October 30, 2017
- October 20, 2015: View a new infographic (PDF, 5.5 MB) about the CDC Strategic National Stockpile
- October 15, 2015: CDC's Center for Emerging and Zoonotic Infectious Diseases has released a new report: Innovative Technologies (PDF, 4.5 MB)
- October 14, 2015: MCMi email update - New EID workshop - clinical trial designs for emerging diseases | Ebola one year later - subscribe
- October 13, 2015: Broad Agency Announcement (BAA) for the Advanced Research and Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures for BARDA - closing date for applications is October 31, 2017
October 12, 2015: IOM workshop summary available: Rapid Medical Countermeasure Response to Infectious Diseases - Enabling Sustainable Capabilities Throughout Ongoing Public- and Private-Sector Partnerships
October 5, 2015: BARDA Issues 3 New Broad Agency Announcements for Biodefense
September 30, 2015: HHS enhances preparedness with new products to treat severe burns â€‹- disaster readiness could make new treatment options available for routine burn care, mass casualties
September 30, 2015: HHS launches resources system to improve disaster preparedness
September 30, 2015: MCMi email update - Be prepared | October events | MCM news | deadline reminders
September 30, 2015: National Preparedness Month: FDA and Access to Medical Countermeasures During Public Health Emergencies (FDA Voice blog)
September 29, 2015: HHS advances development of novel drug to treat influenza (monoclonal antibody therapeutic drug)
September 28, 2015: The NIAID/NIH Centers for Medical Countermeasures Against Radiation (CMCR) is now accepting letters of intent (due October 9, 2015) for pilot projects focused on practical approaches for radiation biodosimetry or the development of agents for the mitigation of acute or late radiation effects.
September 28, 2015: HHS sponsors development of drug for hospitalized influenza patients
September 23, 2015: HHS explores new disaster use of approved ‘clot busting’ drug - Drug shows promise as potential lifesaver in mustard gas attack
September 22, 2015: HHS/ASPR project - Mass decontamination research provides new scientific evidence for responders, hospitals to decontaminate chemical terrorism, accident survivors
September 21, 2015: HHS advances development of new monoclonal antibody drug for Ebola
September 18, 2015: FDA Announces First-ever Patient Engagement Advisory Committee
September 16, 2015: HHS enters into strategic alliance to accelerate new antibiotic development - partnership stimulates pipeline of drugs to treat multi-drug resistant bacterial infections
- September 15, 2015: Expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles (PDF, 28 KB) - memo to state and local public health and first responder stakeholders - related: doxycycline and penicillin G procaine for inhalational anthrax (post-exposure)
September 14, 2015: Experimental Ebola vaccine regimen takes new steps under HHS program
September 14, 2015: MCMi email update - Decoding Ebola | September events | MCM news | deadline reminders - subscribe
- September 9, 2015: Announcement of Public Consultation on Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge - HHS intends to hold a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition and will convene a public consultation to seek comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. Written comments can be submitted to https://www.challenge.gov/ for this competition October 1, 2015, 8:30 a.m. EDT to October 6, 2015, 5:00 p.m. EDT. NIH/BARDA public consultation agenda, October 7, 2015 (PDF, 227 KB)
- September 8, 2015: FDA Voice - FDA Taking Genomic Testing to the Next Level
September 8, 2015: New from the National Academies Press - Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense
September 4, 2015: The Hope Multipliers (video, 14:24) - In late 2014, the U.S. Public Health Service Commissioned Corps was activated to respond to the Ebola epidemic in West Africa. Officers were pulled from many different agencies within HHS and other components of the U.S. government. Some of the deployed FDA officers share their experiences in this video.
August 27, 2015: NIH/NIAID research news - NIAID Researchers Advance Development of Universal Flu Vaccine
August 27, 2015: CDC has clarified its guidance regarding personal protective equipment (PPE) for healthcare personnel caring for suspected and confirmed Ebola patients in U.S. healthcare facilities: updated PPE guidance for confirmed Ebola patients - CDC’s PPE guidance for clinically stable persons under investigation for Ebola - CDC Ebola PPE FAQs
August 26, 2015: NIH has announced the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2015. The list (PDF, 322 KB) includes biodefense research priorities (see Table 5). All nominations of pediatric therapeutics for future consideration should be submitted to Dr. Perdita Taylor-Zapata at email@example.com.
August 21, 2015: CDC Grand Rounds - Getting Smart About Antibiotics
August 19, 2015: FDA and CDC release NARMS data - FDA is publishing online data on its collection of bacteria – Salmonella, Campylobacter, E. coli, and Enterococcus – that are found in the guts of animals and humans, collected over the past 19 years as part of the National Antimicrobial Resistance Monitoring System (NARMS). CDC has also announced a new interactive tool, NARMS Now: Human Data.
August 19, 2015: NIH/NIAID research news - NIH scientists and colleagues successfully test MERS vaccine in monkeys and camels
August 17, 2015: HHS ASPR posted a webinar recording - The Healthcare and Public Sector Webinar: Preparedness Grants Opportunities
August 17, 2015: Development of new anthrax vaccine underway with HHS support - Project is the latest in the quest to protect health quickly (post-exposure) in a bioterrorism attack
August 13, 2015: NIH/NIAID research news - NIH-Funded Study Establishes Genomic Data Set on Lassa Virus - Knowledge of Virus Supports Efforts to Develop Medical Countermeasures. The data set is publicly accessible at the National Center for Biotechnology Information's BioProject website under PRJNA254017.
- August 11, 2015: The Drug Shortages 2 app is now available for Android devices on Google Play. Drug Shortages 2 includes an Alerts feature. You can opt in to receive notifications on your mobile device when FDA adds or updates shortage information about a drug product or one or more drugs within a selected therapeutic category. First launched March 4, 2015, the app identifies current drug shortages, resolved shortages and discontinuations of drug products. FDA is currently working on notifications for the iOS version of the mobile app. The app for Apple devices is available for free download via iTunes.
August 11, 2015: FDA Voice - Frances Oldham Kelsey, Ph.D., M.D.: A Pioneer in Public Health and Protection of Patients
August 7, 2015: The NIH National Institute of Environmental Health Sciences (NIEHS) Worker Training Program invites applications for cooperative agreements to support the development and implementation of occupational safety and health and infection control training programs for workers who may be at risk during infectious disease outbreaks. Respond by October 21, 2015.
August 7, 2015: Final rule - HHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus and other potential pandemic strains, such as H5N1 avian influenza. Also see Countermeasures Injury Compensation Program.
August 4, 2015: FDA Safety Communication: Supplemental Measures to Enhance Duodenoscope Reprocessing
August 4, 2015: CDC modeling projects growth of drug-resistant infections and C. difficile - The latest CDC Vital Signs (PDF, 2.1 MB) includes mathematical modeling that projects increases in drug-resistant infections and Clostridium difficile without immediate, nationwide improvements in infection control and antibiotic prescribing. Also see Stop the Spread of Antibiotic Resistance (video, 3:23).
August 3, 2015: MCMi email update - New Emergency Use Authorizations - Ebola and MERS-CoV - subscribe to these updates
July 31, 2015: FDA issued an EUA for the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, in laboratories or facilities adequately equipped, trained, and capable of such testing.This point of care test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. more
- July 29, 2015: FDA released a new report, Science Moving Forward (PDF, 1.4 MB), a progress report to the FDA Science Board - read an FDA Voice blog post about this report
- July 28, 2015: The White House published a fact sheet on the Global Health Security Agenda
- July 28, 2015: NIH/NIAID research news - Experimental MERS Vaccine Shows Promise in Animal Studies
- July 24, 2015: Funding opportunity - NIH and CDC are soliciting proposals from small businesses to conduct research and development, including possible medical countermeasure-related research - respond by October 16, 2015
- July 24, 2015: FDA Voice blog - Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs
- July 21, 2015: RFI - The Defense Threat Reduction Agency (DTRA) is seeking sources of fundamental toxin characterization, and new or repurposed medical countermeasures against naturally occurring biological toxins. Respond by August 28, 2015.
- July 21, 2015: FDA Voice video blog - FDA Science Forum 2015: Views of FDA
- July 21, 2015: NIH/NIAID research news - Virus-Like Particle Vaccine Protects Mice from Many Flu Strains
- July 20, 2015: HHS partnership advances experimental Ebola drug - Department calls on Centers for Innovation in Advanced Development and Manufacturing
- July 17, 2015: New exercises released - The Food Related Emergency Exercise Bundle (FREE-B) is a compilation of scenarios based on both intentional and unintentional food contamination events, designed with to assist government regulatory and public health agencies in assessing existing food emergency response plans, protocols and procedures.
July 17, 2015: FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® MERS-CoV RT-PCR Kit U.S. for the in vitro qualitative detection of RNA from the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). more
- July 16, 2015: CDC is proposing to add certain H5N1 influenza virus strains to the list of HHS select agents and toxins. Comment by September 14, 2015.
- July 16, 2015: Innovation at FDA - These updated web pages outline how FDA is helping to speed treatments and cures to patients. The new section includes news, blog posts, speeches, fact sheets, and reports.
- July 15, 2015: HHS has published a Response and Recovery Resources Compendium, a comprehensive web-based repository of HHS resources and capabilities available to Federal, State, local, territorial and tribal stakeholders before, during, and after public health and medical incidents.
- July 14, 2015: Funding opportunity - NIAID is seeking development of therapeutic products for use in post-event settings following the release of a NIAID Category A, B, or C Priority Pathogen, or in response to naturally occurring outbreaks of infectious diseases caused by these pathogens. Responses are due August 31, 2015.
- July 9, 2015: CDC report - The Road to Zero: CDC's Response to the West African Ebola Epidemic, 2014-2015
- July 8, 2015: FDA is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
- July 6, 2015: HHS awards improve health care, public health preparedness - Health departments across the country will receive more than $840 million in cooperative agreements from the U.S. Department of Health and Human Services to improve and sustain emergency preparedness of state and local public health and health care systems.
- July 1, 2015: FDA Medical Countermeasures Initiative update - MCMi annual program update: CRBN, Ebola, research + more - subscribe to these updates
- July 2015: FDA white paper - Targeted Drug Development: Why Are Many Diseases Lagging Behind?
- July 2015: National Academies Press publication - Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense
- June 30, 2015: View the MCMi Fiscal Year 2014 Program Update (web version) - printable PDF (1.3 MB)
- June 30, 2015: View presentations and recordings from FDA's Office of Regulatory Science and Innovation Science Symposium, held April 27, 2015, and the 2015 FDA Science Forum, held May 27-28, 2015
- June 17, 2015: From NIH - Study of Ebola survivors opens in Liberia: Trial to examine long-term health effects of Ebola virus disease
June 16, 2015: FDA has a new Risk Evaluation and Mitigation Strategies site, a centralized, user-friendly source for approved REMS
- June 15, 2015: The HHS Assistant Secretary for Preparedness and Response (ASPR) has introduced a new resource, the ASPR Technical Resources Assistance Center and Information Exchange (ASPR TRACIE), a new information gateway that connects public health and medical professionals with the emergency preparedness, response and recovery information they need.
- June 12, 2015: HHS selects nine regional Ebola and other special pathogen treatment centers, and pursues fast, easy test to detect Ebola virus infections
- June 9, 2015: FDA Medical Countermeasures Initiative update - Ebola vaccine presentations + MCM deadline reminders - subscribe to these updates
- June 3, 2015: Blog post from Sec. Burwell - White House Forum on Antibiotic Stewardship Convenes Government and Private Sector Leaders Committed to Improving Antibiotic Prescribing, including related commitments from HHS agencies
- June 3, 2015: From the White House Office of Science and Technology Policy, Upping Our Game for Disaster Preparedness and Response
- June 2, 2015: Highly-pathogenic avian influenza A H5 viruses have been identified in birds in the United States since December 2014. CDC has issued a Health Alert Network (HAN) Advisory to notify public health workers and clinicians of the potential for human infection with these viruses and to describe CDC recommendations for patient investigation and testing, infection control including the use of personal protective equipment, and antiviral treatment and prophylaxis.
- June 2, 2015: HHS intends to hold a prize competition for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. NIH and BARDA are sponsoring the prize competition, and seek public comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. Comment by July 17, 2015.
- June 2, 2015: FDA regulation to help ensure judicious use of antibiotics in food-producing animals - related FDA Voice blog: Veterinary Feed Directive Will Protect Both People and Animals - related fact sheet from the White House: Over 150 Animal and Health Stakeholders Join White House Effort to Combat Antibiotic Resistance - related information from CDC: Federal Engagement in Antimicrobial Resistance
- June 2, 2015: Presentations and webcast recordings are now available for the May 12, 2015 Vaccines and Related Biological Products Advisory Committee meeting on Ebola vaccines
- May 27, 2015: HHS is requesting public comment on the Assistant Secretary for Preparedness and Response (ASPR) Public Access Plan for Federally Funded Research. Submit comments via email to firstname.lastname@example.org by June 26, 2015.
- May 21, 2015: World Health Assembly: Health Threats Don’t Recognize Borders - blog post by HHS Secretary Sylvia Mathews Burwell
- May 12, 2015: The FDA Vaccines and Related Biological Products Advisory Committee met in open session to discuss the development and licensure of Ebola vaccines (Silver Spring, MD and webcast) (Federal Register notice) - Agenda (PDF, 52 KB) - Briefing Document: Licensure of Ebola Vaccines: Demonstration of Effectiveness (PDF, 146 KB) - additional meeting materials will be posted here when available
- May 12, 2015: FDA issued an EUA for the CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) for the in vitro qualitative detection of RNA from the Enterovirus D68 (EV-D68) strains detected in North America in 2014. This device will be distributed by CDC to qualified laboratories designated by CDC. more
- May 11, 2015: Accurate and simultaneous identification of influenza viruses - FDA scientists showed that a "one-test-fits-all” technique they developed can simultaneously detect different influenza viruses in a single sample and determine their genetic makeup
- May 11, 2015: FDA is requesting nominations for the Vaccines and Related Biological Products Advisory Committee - submit by June 10, 2015 (Federal Register notice)
May 8, 2015: Recent developments in combating antibiotic resistance: FDA's role - speech by Acting Commissioner Stephen Ostroff, MD at the ASM Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens, Washington, DC
May 8, 2015: FDA Medical Countermeasures Initiative update - Plague treatment approval + May 12 Ebola vaccine briefing doc - subscribe to these updates
May 6, 2015: “Today I am Healed. Tomorrow I Return to Heal Another” - blog post by U.S.Surgeon General Vice Admiral Vivek H. Murthy on his recent trip to Liberia with the U.S. Public Health Service
April 27, 2015: FDA is accepting applications for the Food Emergency Response Network (FERN ) Cooperative Agreement Program for Microbiological, Chemical, or Radiological laboratories. Apply by June 29, 2015.
- April 23, 2015: The National Library of Medicine announced a funding opportunity for small projects to improve access to disaster medicine and public health information for health care professionals, first responders and others that play a role in health-related disaster preparedness, response and recovery. Proposals due July 6, 2015.
- April 22, 2015: The HHS Secretary issued a PREP Act declaration, effective February 27, 2015, to provide liability protection for activities related to Ebola virus disease therapeutics consistent with the terms of the declaration. (Federal Register notice - about the PREP Act)
- April 21, 2015: RFI - Innovations in Medical Countermeasure Continuous Manufacturing (FedBizOpps) - responses due by May 20, 2015
- April 17, 2015: FDA approves radiation medical countermeasure - FDA approves Neupogen® for treatment of patients with radiation-induced myelosuppression following a radiological/nuclear incident. Neupogen® is the first FDA-approved medical countermeasure to increase survival in patients exposed to myelosuppressive doses of radiation.
- April 8, 2015: FDA Voice: Providing timely patient access to high-quality, safe and effective medical devices - includes information about the Expedited Access Pathway Program and two new CDRH guidance documents
- April 8, 2015: CDRH invites medical device industry, academia, and health care facilities to apply to participate in its 2015 Experiential Learning Program. Submit request for participation by May 8, 2015.
- April 3, 2015: FDA is requesting comments on identifying potential biomarkers for qualification and describing contexts of use to address areas important to drug development - comments due May 15, 2015
- March 27, 2015: FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies
- March 27, 2015: HHS is accepting nominations to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria - due by April 29, 2015 (Federal Register notice)
- March 27, 2015: The White House released the National Action Plan for Combating Antibiotic-Resistant Bacteria (PDF, 442 KB) - more about the plan
- March 25, 2015: FDA approves treatment for inhalation anthrax - FDA approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs. Anthrasil was approved under the Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans.
- March 25, 2015: From the White House National Security Council blog - Progress Report: Getting to Zero Ebola Cases in West Africa
- March 24, 2015: FDA Ebola response update: Ebola vaccine meeting, 9th EUA - subscribe to these updates
March 23, 2015: FDA issued an EUA to authorize emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus.The test should be performed in CLIA moderate and high complexity laboratories, or similarly qualified non-U.S. laboratories, by personnel who have received specific training on the use of the Xpert® Ebola Assay on GeneXpert Instrument Systems. more
- March 23, 2015: HHS seeks to develop improved anthrax vaccine
March 19, 2015: FDA Voice blog post - Turning the Tide on Ebola: A first-hand account from Liberia, from one of FDA's U.S. Public Health Service officers
March 18, 2015: FDA and the Pharmacy Board of Sierra Leone (PBSL) signed reciprocal agreements (PDF, 702 KB) to help facilitate communications between FDA and the PBSL on medical products used, or proposed to be used, for Ebola-related purposes as part of cooperative regulatory activities. FDA signed similar agreements (PDF, 822 KB) with the Liberian Medicines and Health Products Regulatory Authority (LMHRA) in February.
March 18, 2015: Comments on the CDRH Emergency Shortages Data Collection System are requested by May 18, 2015.
March 16, 2015: From the White House Office of Science and Technology Policy, Continuing Engagement to Ensure the Nation’s Biosafety - public comments requested by March 30, 2015 on the impact of select agent regulations
March 16, 2015: At the request of the manufacturer, FDA reissued the ReEBOV™ Antigen Rapid Test Emergency Use Authorization, first issued in February 2015, to allow distribution by certain authorized distributors. The Instructions for Use (PDF, 474 KB) have also been updated to incorporate these amendments. Additional technical information
March 12, 2015: FEMA is accepting applications for the 2015 Individual and Community Preparedness Awards. Submit nominations by April 10, 2015.
March 10, 2015: The FDA Commissioner's Fellowship program will accept applications from healthcare professionals, scientists and engineers March 16 - April 24, 2015. The program combines rigorous graduate-level coursework with the development of a regulatory science research project, including several in medical countermeasure-related areas.
March 6, 2015: FDA approves first biosimilar product Zarxio - Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. (More about filgrastim including its potential for use in emergency situations, from CDC.)
March 6, 2015: FDA approves new antifungal drug Cresemba, the sixth approved antibacterial or antifungal drug product designated as a Qualified Infectious Disease Product (QIDP). This designation is given to antibacterial or antifungal drug products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.
March 2, 2015: In response to CDC’s request, FDA reissued the two October 10, 2014 CDC EUAs in their entirety. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument. The Instructions for Use and Fact Sheets for Health Care Providers have also been updated to incorporate these amendments (updated attachments). The amendments also allow the future use of “other authorized instruments,” of “other extraction methods” and of “other authorized specimen types” when requested by CDC and concurred with by FDA. more
March 2, 2015: In response to BioFire Defense, LLC’s request, FDA reissued (PDF, 326 KB) the October 25, 2014 FilmArray NGDS BT-E Assay EUA in its entirety. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. The Instructions for Use (PDF, 740 KB) and Fact Sheet for Healthcare Providers (PDF, 40 KB) have also been updated to incorporate this amendment. The amendments also allow the future use of “other specimen types” when requested by BioFire Defense and concurred with by FDA. more
March 2015: Updated book chapter - Courtney B, Sadove E. Medical Countermeasures: Emergency Preparedness and Response Roles and Authorities, in FOOD AND DRUG LAW AND REGULATION (3rd ed. 2015). (David G. Adams, Richard M. Cooper, Martin J. Hahn, Jonathan S. Kahan, eds.).
February 27, 2015: NIH news release - Liberia-U.S. Clinical Research Partnership Opens Trial to Test Ebola Treatments: Initial Study Will Evaluate Experimental Drug Cocktail ZMapp
February 27, 2015: Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 - On February 6, 2015, the HHS Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad that involves enterovirus D68 (EV-D68). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68.
February 27, 2015: CDC is considering removal of six biological agents from the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Comment by April 28, 2015.
February 26, 2015: Presidential Commission for the Study of Bioethical Issues - Bioethics Commission Releases Brief on Ebola and Ethics Preparedness for Public Health Emergencies - blog post - brief - full report (PDF, 1.7 MB)
February 26, 2015: Testimony - FDA's Dr. Luciana Borio joined other HHS officials on a panel - Medical and Public Health Preparedness and Response: Are We Ready for Future Threats (U.S. Senate Committee on Health, Education, Labor and Pensions)
February 25, 2015: FDA approves new antibacterial drug Avycaz, the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP). This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.
February 25, 2015: HHS publications - The 2014 Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategy and Implementation Plan highlights PHEMCE accomplishments since 2012 and lays out medical countermeasure priorities for HHS, in collaboration with its interagency partners. The PHEMCE focuses on researching, developing, purchasing and effectively using these medical countermeasures in public health emergencies.
February 24, 2015: FDA granted an Emergency Use Authorization (EUA) for Corgenix’s ReEBOVTM Antigen Rapid Test. This is the first rapid assay to detect Zaire Ebola virus authorized for use during the current Ebola epidemic in West Africa. The authorized ReEBOV™ Antigen Rapid Test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. more
February 23, 2015: BAA funding - Advanced Research and Development of Regulatory Science including medical countermeasure areas of interest - accepting BAA responses until February 19, 2016
February 20, 2015: HHS publications - The National Health Security Strategy and Implementation Plan (NHSS/IP) 2015-2018 serves as a national framework to strengthen and sustain communities’ abilities to prevent, protect against, mitigate the effects of, respond to, and recover from incidents with negative health consequences. The National Health Security Review (NHSR) 2010-2014 describes progress the nation has made—along with its persistent challenges—in strengthening national health security over the past four years.
February 19, 2015: CDC Public Health Matters Blog - CDC's CHEMPACK Program--The Stockpile that may protect you from a chemical attack
February 17, 2015: CBER Regulatory Site Visit Training Program (RSVP) - This training program is intended to give CBER staff an opportunity to visit biologics facilities, to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. Biologics facilities interested in participating should contact CBER by March 19, 2015. (Federal Register notice)
February 13, 2015: Announcement of a draft NIH policy on dissemination of NIH-funded clinical trial information - draft policy to promote broad and responsible dissemination of information on clinical trials funded by the NIH through registration and submission of summary results information to ClinicalTrials.gov - submit comments by March 23, 2015
February 5, 2015: FDA's Dr. Luciana Borio discussed ethical issues associated with research in the context of a public health emergency, with an emphasis on the current Ebola epidemic, at the Presidential Commission for the Study of Bioethical Issues public meeting - webcast recording
February 4, 2015: In an FDA Voice blog post, Commissioner Hamburg summarizes FDA accomplishments in 2014, including antimicrobial resistance and Ebola response activities
February 3, 2015: FDA’s Role in Preventing Influenza and Protecting the American Public Through Vaccination - testimony from Karen Midthun, MD to the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce
February 2, 2015: NIH/NIAID news release: Ebola Vaccine Trial Opens in Liberia - Study Led by Liberia-NIH Partnership Will Test Two Experimental Vaccines; related: Q&A on PREVAIL Phase 2/3 clinical trial of investgational Ebola vaccines
January 30, 2015: FDA’s investigation into patients being injected with simulated IV fluids continues - FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate multiple instances of simulated saline solution being administered to patients and to alert health care providers and regulatory officials throughout the country to raise awareness of the potential risk. (See also: Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected)
January 27, 2015: Update on Ebola clinical trial research - transcript from a January 22, 2015 media briefing on the status of clinical trials for Ebola vaccines and therapeutics from HHS officials including NIAID/NIH, CDC, BARDA and FDA
January 21, 2015: CDC has published a report from its 2013 Melioidosis Diagnostic Workshop.
January 21, 2015: FEMA is seeking nominations for its Youth Preparedness Council (applications due March 2, 2015), and its National Advisory Council , which advises the FEMA Administrator on all aspects of emergency management (applications due February 16, 2015).
January 15, 2015: CDC Ebola preparedness grant funding announcement - Hospital Preparedness Program (HPP) and Public Health Emergency Preparedness (PHEP) Cooperative Agreements/PHEP Supplemental for Ebola Preparedness and Response Activities - applications due February 20, 2015
January 14, 2015: FDA’s investigation into patients being injected with simulated IV fluids continues (also see Product shortages and availability below, and Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected)
January 6, 2015: The National Institutes of Health (NIH) is seeking public comments on a draft policy to promote the use of a single Institutional Review Board of record for domestic sites of multi-site studies funded by the NIH. (Federal Register notice)
- December 23, 2014: FDA issued an EUA to authorize use of the LightMix® Ebola Zaire rRT-PCR Test for the presumptive detection of the Ebola Zaire virus in a preparation of whole blood from individuals with signs and symptoms of Ebola disease. The test runs only on specified instruments used by CLIA high complexity laboratories or similarly qualified non-U.S. laboratories. more
- December 23, 2014: HHS blog - Back from fighting Ebola on the front lines
December 22, 2014: FDA approved Rapivab (peramivir) to treat influenza infection in adults. Rapivab is the first neuraminidase inhibitor approved for intravenous (IV) administration and is administered as a single IV dose. Other neuraminidase inhibitors approved by the FDA to treat influenza include oseltamivir, administered orally, and zanamivir, which is inhaled. Related, from the ASPR blog: BARDA-sponsored flu drug earns FDA approval
December 19, 2014: FDA approved new antibacterial drug Zerbaxa, (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). Zerbaxa is the fourth new antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval.
December 19, 2014: FDA approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections. On December 16, 2014, FDA also approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections.
December 19, 2014: The HHS Assistant Secretary for Preparedness and Response (ASPR) released the first evidence-based planning guidance for patient decontamination.
December 18, 2014: FDA Strategies for Combatting Antimicrobial Resistance - remarks by FDA Commissioner Dr. Margaret Hamburg at A One Health Colloquium in London, England
December 12, 2014: Public workshop: Immunology of Protection from Ebola Virus Infection (Rockville, MD and webcast) - The purpose of this workshop was to discuss important aspects of Ebola virus and vaccine immunology in order to inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola. Webcast recording now available
December 12, 2014: HHS blog by Secretary Burwell - A Timely Recognition (on "The Ebola Fighters" as Time Magazine Person of the Year)
December 9, 2014: HHS news release - Secretary Burwell issues declaration under PREP Act to support development of Ebola vaccines
December 8, 2014: The Presidential Commission for the Study of Bioethical Issues is requesting public comment on ethical considerations and implications of public health emergency response, with a focus on the current Ebola virus disease epidemic. Comments due February 6, 2015. Related: February 5-6, 2015 meeting agenda
December 3, 2014: Evaluating Ebola Therapies — The Case for Randomized, Controlled Trials (RCTs) - FDA Perspective in the New England Journal of Medicine
December 3, 2014: NIH news release - NIH takes step to speed the initiation of clinical research by ensuring use of single IRB
December 2, 2014: White House fact sheet: Update on the Ebola response
December 2, 2014: HHS news release - 35 U.S. hospitals designated as Ebola treatment centers
November 26, 2014: At the manufacturer's request, FDA reissued Emergency Use Authorization of the RealStar® Ebolavirus RT-PCR Kit 1.0 to detect Ebola viruses. More (also see Emergency Use Authorization below)
November 25, 2014: BARDA Sources Sought Notice: Verification, Validation and Acquisition of a Radiation Biodosimetry High Throughput Test - responses due December 15, 2014
November 24, 2014: View slides and listen to the recording of an FDA Basics webinar on drug shortages
November 21, 2014: MCMi email update - FDA Ebola response update: New workshop, Warning Letters - subscribe to these updates
November 19, 2014: FDA and the Federal Trade Commission have issued Warning Letters to three additional firms marketing products that claim to prevent, treat or cure infection by the Ebola virus: Ebola-C Inc., Bodyhealth.com LLC and LifeSilver. More
November 19, 2014: Testimony: FDA's Dr. Luciana Borio spoke as part of a panel on Examining Medical Product Development in the Wake of the Ebola Epidemic (House Committee on Energy and Commerce, Subcommittee on Health hearing)
November 14, 2014: The National Association of County & City Health Officials (NACCHO) is seeking past authors and new submissions for its Medical Countermeasure Toolkit (formerly known as the Stockbox)
November 5, 2014: Director of Antimicrobial Products Dr. Edward Cox and Assistant Commissioner for Counterterrorism Policy Dr. Luciana Borio participated in a media briefing on Ebola at the American Society of Tropical Medicine and Hygiene Annual Meeting . View the full list of speakers (PDF, 269 KB), and listen to the recording (1 hour, 14 minutes).
October 28, 2014: FDA as part of a coordinated global response on Ebola - FDA has an Ebola Task Force with wide representation from across FDA to coordinate our many activities. We are actively working with federal colleagues, the medical and scientific community, industry, and international organizations and regulators to help expedite the development and availability of medical products – such as treatments, vaccines, diagnostic tests, and personal protective equipment – with the potential to help bring the epidemic under control as quickly as possible. Read more in a blog post by Commissioner Hamburg
October 25, 2014: FDA authorized emergency use of two Biofire Defense diagnostic tests to detect the Ebola Zaire virus. (Additional info. under Emergency Use Authorization tab below, and on the MCMi EUA page.)
October 22, 2014: A Pivotal Moment for the Treatment of Rare Diseases - Address by FDA Commissioner Hamburg to the NORD Rare Diseases and Orphan Products Breakthrough Summit , including information about FDA's response to the Ebola outbreak
October 16, 2014: National Journal interview with Dr. Luciana Borio - Ebola has the FDA Working Overtime on Reviewing Experimental Drugs
October 16, 2014 - HHS press release - HHS advances development of third Ebola vaccine
October 16, 2014 – Testimony - FDA’s Dr. Luciana Borio spoke as part of a panel on Examining the U.S. Public Health Response to the Ebola Outbreak (House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations hearing)
October 9, 2014 - MCMi email update - Fall events, MCM resources, preparedness contracts, and more - subscribe to these updates
October 9, 2014: Regulatory science collaborations support emergency preparedness - learn more about how FDA is helping better prepare our nation to use medical countermeasures--products that can save lives--in emergencies
October 8, 2014: FDA Voice blog on cybersecurity of medical devices - FDA and the Cybersecurity Community: Working Together to Protect the Public Health
October 1, 2014: FDA press release - FDA takes steps to strengthen cybersecurity of medical devices (guidance)
September 29, 2014: HHS BARDA contract award - New device could reduce time needed to test for bacteria, such as anthrax
September 29, 2014: HHS News Release - HHS funds drug to treat severe infections and prevent cytokine storm. Therapy modulates inflammatory response and may help treatment of “flesh-eating bacteria”and biothreats.
September 26, 2014: Remarks from FDA Commissioner Hamburg on the dedication of FDA's new Biodefense Laboratory Complex at White Oak. The new facility will support medical countermeasures, including pandemic influenza preparedness, as well as facilitating development of products to prevent global and emerging diseases.
September 25, 2014: Publication - Regulatory Underpinnings of Global Health Security: FDA's Role in Preventing, Detecting, and Responding to Global Health Threats
September 24, 2014: FDA has issued Warning Letters to three firms marketing products that claim to prevent, treat or cure infection by the Ebola virus. There are no approved treatments for Ebola available for purchase on the Internet. more
September 23, 2014: Three encouraging steps towards new antibiotics - blog post by FDA Center for Drug Evaluation and Research director Dr. Janet Woodcock
September 23, 2014: FDA Acting Deputy Chief Scientist and Assistant Commissioner for Counterterrorism Policy Luciana Borio participated in a symposium entitled The Ebola Crisis: Context, Systemic Challenge, Consequences. Dr. Borio discussed FDA’s role in responding to the outbreak. The meeting was hosted by Georgetown University, Washington, D.C., and open to the public.
September 18, 2014: White House blog - New Executive Actions to Combat Antibiotic Resistance and Protect Public Health, including an Executive Order, National Strategy for Combating Antibiotic-Resistant Bacteria (PDF, 481 KB), and a new report (PDF, 667 KB) from the President's Council of Advisors on Science and Technology (PCAST)
September 17, 2014: Testimony - FDA’s Dr. Luciana Borio spoke as part of a panel on Global Efforts to Fight Ebola (House Committee on Foreign Affairs, Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations hearing)
September 4, 2014 - Medicines regulators worldwide have committed to enhanced cooperation to speed access to investigational Ebola drugs (statement from the International Coalition of Medicines Regulatory Authorities)
August 25, 2014 – FDA and the World Health Organization Department of Essential Medicines and Health Products (WHO EMP) have signed an agreement (PDF, 550 KB) to help facilitate communications between FDA and WHO EMP regarding an actual or potential public health crisis or public health emergency of international concern, such as the Ebola outbreak in West Africa. The agreement allows sharing of information that is non-public but important to address public health emergencies between the organizations. More information about FDA’s international arrangements
August 22, 2014: FDA Voice blog post: FDA works to mitigate the West Africa Ebola outbreak - The world is witnessing the devastating effects of the Ebola virus outbreak in West Africa, the worst Ebola outbreak in recorded history. We at FDA are dedicated to helping end this outbreak as quickly as possible, and to help prevent future outbreaks like this. Read more
August 22, 2014: FDA has a new web page dedicated to the 2014 Ebola outbreak in West Africa, where we will post FDA updates related to this outbreak, including "fast facts," statements, outbreak-related contact information, frequently requested links, and information on FDA's role, Emergency Use Authorization, and more. - Español - Français
August 20, 2014: Responding to Ebola: The View From the FDA - As part of FDA's expert commentary and interview series, Medscape spoke with FDA Acting Deputy Chief Scientist and Assistant Commissioner for Counterterrorism Policy Luciana Borio, MD.
August 15, 2014: MCMi email update - September events, and presentations from antimicrobial resistance workshop - subscribe to these updates
August 15, 2014: For healthcare professionals who administer inactived influenza vaccines - FDA Updated Communication on Use of Jet Injectors with Inactivated Influenza Vaccines
August 14, 2014: FDA statement - FDA is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.
August 6, 2014: FDA news release - FDA approves Orbactiv to treat skin infections - Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is the third new antibacterial drug approved by the FDA this year to treat ABSSSI.
August 1, 2014: HHS news release - New committee will advise HHS on children’s health in disasters
July 21, 2014: DARPA is soliciting proposals for research supporting the potential use of Bdellovibrio and/or Micavibrio bacterial predators as therapeutics against infections caused by Gram-negative antibiotic-resistant and priority threat pathogens. BAA responses due September 23, 2014.
July 2014: Funding Opportunity Announcements - NIAID is soliciting applications for those interested in joining the Centers for Medical Countermeasures Against Radiation Consortium; letters of Intent due September 3, 2014. Development of Novel Therapeutics for Select Pathogens (NIAID). Letters of intent due September 19, 2014.
July 17, 2014: Federal Register notice: Interagency Task Force on Antimicrobial Resistance (ITFAR) Public Meeting. This meeting, originally scheduled for September 4, 2014, has been postponed.
June 20, 2014: FDA news release - FDA approveds Sivextro to treat skin infections - FDA today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is the second new antibacterial drug approved by the FDA in the past month to treat ABSSSI.
June 18, 2014: NIAID seeking proposals - The Radiation and Nuclear Countermeasures Program seeks proposals for multidisciplinary basic and translational research to support the development of new medical products that will assess, diagnose, mitigate and/or treat the short- and long-term consequences of radiation exposure after a radiological/nuclear terrorist event or accidental exposure. Submissions due October 3, 2014.
June 17, 2014: HHS Statement - "This week, our nation reached a milestone in battling influenza, with the U.S. Food and Drug Administration’s first approval to manufacture seasonal influenza vaccine using cell-based technology in a U.S. facility. That facility, owned by Novartis of Basel, Switzerland, and located in Holly Springs, N.C., now can manufacture cell-based vaccine against seasonal as well as pandemic influenza viruses. This new capability demonstrates the effectiveness of a multi-use approach to emergency preparedness." Read the full statement
HHS Assistant Secretary for Preparedness and Response (ASPR) blog series: Combatting Antibiotic Resistance - This series is designed to highlight the antibiotic resistance crisis and some of the actions that are being taken to mitigate the threat.
June 6, 2014 FDA presentation: MCM policy updates following the 2013 enactment of PAHPRA (PDF, 261 KB)
June 2-3, 2014: 2014 MCMi Regulatory Science Symposium - Webcast Recordings
June 2, 2014: FDA News Release - FDA launches openFDA to provide easy access to valuable FDA public data - openFDA site
May 29, 2014: FDA issues revised draft guidance: Product Development Under the Animal Rule (PDF, 2 MB) - This revised draft guidance replaces the 2009 draft guidance for industry entitled “Animal Models--Essential Elements to Address Efficacy Under the Animal Rule” and addresses a broader scope of issues for products developed under the Animal Rule.
May 29, 2014: FDA issues final guidance: Expedited Programs for Serious Conditions -- Drugs and Biologics (PDF, 276 KB) - Related FDA Voice blog post: FDA’s Final Guidance on Expedited Drug Approvals: Fueling Innovation and Helping Patients
May 23, 2014: FDA News Release - FDA approves Dalvance (dalbavancin), a new antibacterial drug to treat adults with skin infections. Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. It is an IV treatment intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes.
Appplications due for Regulatory Science Student Internship Program May 15, 2014.
May 9, 2014: FDA News Release - FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks
May 5, 2014: News Release from Wyss - Bone marrow-on-a-chip unveiled (Nature Methods abstract: Bone marrow–on–a–chip replicates hematopoietic niche physiology in vitro )
April 22, 2014: Collaboration and Medical Countermeasures: Furthering Regulatory Science - FDA Voice blog post by FDA Chief Scientist Dr. Stephen Ostroff
April 22, 2014: FDA News Release - FDA proposes new expedited access program for medical devices that address unmet medical needs
April 16, 2014: HHS News Release - New National Biodefense Science Board members to advise HHS
April 11, 2014: HHS News Release - Take action to be ready and resilient: statement by Assistant Secretary for Preparedness and Response Nicole Lurie, MD
April 10, 2014: NIH News Release - NIH funds influenza research and surveillance network
April 3, 2014: FDA News Release - FDA allows marketing for first-of-kind dressing to control bleeding from certain battlefield wounds
March 11, 2014: HHS News Release - HHS establishes new network to perform clinical studies; network can prepare, conduct clinical studies for drugs to protect health in emergencies
February 13, 2014: HHS News Release - Nations Commit to Accelerating Progress against Infectious Disease Threats
February 5, 2014: HHS News Release - HHS funds drug for bioterrorism, antimicrobial-resistant infections
January 2014: FDA issued a PAHPRA question and answer document (PDF, 762 KB) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies
- December 20, 2013: FDA News Release - FDA Proposes New Food Defense Rule
- November 22, 2013: FDA News Release - FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza
- September 26, 2013 HHS News Release - HHS boosts stockpile of products to treat acute radiation syndrome; contracts allow repurposing of a commercial cancer therapy for use in emergencies
- August 15, 2013: FDA Drug Safety Communication - FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection
- August 12, 2013: FDA News Release - FDA awards contract to develop promising new technology to test radiation countermeasures
- March 22, 2013: FDA News Release - FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes
- March 13, 2013: HHS News Release - Assistant Secretary Nicole Lurie Statement on the Pandemic and All Hazards Preparedness Reauthorization Act
- March 13, 2013: The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) passed
- January 16, 2013: FDA News Release - FDA approves new seasonal influenza vaccine developed using new technology
- December 21, 2012: FDA News Release - FDA expands Tamiflu's use to treat children younger than 1 year
- December 14, 2012: FDA News Release - FDA approves raxibacumab to treat inhalational anthrax,
the first monoclonal antibody approved using the Animal Efficacy Rule
- December 13, 2011: FDA News Release - FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
- November 20, 2012: FDA News Release - FDA approves first seasonal flu vaccine manufactured using cell culture technology Held by the Strategic National Stockpile - Final Rule
- October 12, 2012: FDA Joins Multiagency Partnership at Fort Detrick (National Interagency Confederation for Biological Research, NICBR)
- August 13, 2012: FDA News Release - FDA approves vaccines for the 2012-2013 influenza season
- June 21, 2012: Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy (PDF, 2.80 MB)
- June 18, 2012: HHS News Release - HHS announces 10 new centers to develop & manufacture medical countermeasures
- April 27, 2012: FDA News Release - FDA approves antibacterial treatment for plague
- February 2012: Guidance on Postmarket Adverse Event Reporting during an influenza pandemic (PDF, 217.52 KB)
- February 6, 2012: Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile - Final Rule
- September 28, 2011: FDA News Release - FDA clears first single use face mask for children
- July 25, 2011: FDA News Release - FDA Center for Drug Evaluation and Research develops strategic science and research agenda
- July 18, 2011: FDA News Release - FDA approves vaccines for 2011-2012 flu season
- May 20, 2011: FDA News Release - FDA clears first test to diagnose Q fever in overseas military personnel
- August 19, 2010: FDA Speech - FDA Commissioner Margaret Hamburg Announces Roll-Out of FDA's Medical Countermeasures Initiative (MCMi)