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.
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 - 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)