Ebola response updates from FDA - Emergency Use Authorization, guidance, events, and more
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 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
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. Additional technical information - also see Emergency Use Authorization below
- 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)
- MCMi Fiscal Year 2015 Program Update (web version) - printable PDF (2.7 MB)
- For more news and events by category, view the drop-down sections below.
- 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 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 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 15, 2016: MCMi email update - Zika reference materials for diagnostic manufacturers + better understanding Ebola's after-effects to help find new treatments - subscribe - let us know how we can make this newsletter more useful for you: take our survey
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 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.
- For more news, visit our News Archive, or view previous MCMi newsletters
July 27-29, 2016: Society for Disaster Medicine & Public Health (SDMPH) 2nd Annual Meeting (Rockville, MD) (fee)
August 1, 2016: Workshop - Integration of FDA and NIOSH Evaluation Processes of Respiratory Protective Devices for Health Care Workers (Washington, DC), hosted by the National Academies, Health and Medicine Division
August 3-4, 2016: CDC will host a public webcast to address import and export permit regulations for infectious biological agents, infectious substances, and vectors; and import and export permit exemptions. Submit registration requests by July 22, 2016.
August 4, 2016: CDER Small Business and Industry Assistance (CDER SBIA) Webinar: Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know - also see: Guidance: Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF, 111 KB)
August 8, 2016: Webinar for FDA Final Guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices, 1:00 - 2:30 p.m. ET, registration is not necessary - view the guidance (PDF, 696 KB)
- August 21-24, 2016: Public Health Informatics Conference (Atlanta, GA), hosted by CDC and NACCHO (fee)
September 8, 2016: Public Workshop - Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval (Silver Spring, MD and webcast) - register by August 1, 2016 to attend in person or view the webinar
September 12-13, 2016: Public Hearing - Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (Bethesda, MD and webcast)
September 12-13, 2016: Public Workshop - Pediatric Clinical Investigator Training (Bethesda, MD and webcast), hosted by the FDA Office of Pediatric Therapeutics and the Eunice Kennedy Shriver National Institute of Child Health and Human Development - The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. Register by September 6, 2016. (Federal Register notice)
September 13-14, 2016: Public Workshop - Sequencing Quality Control II - The purpose of the public workshop is to define the scope of project and study designs, and solicit participation of DNA sequencing community and stakeholders for data generation, management, analysis, and interpretation. (Bethesda, MD) (Federal Register notice)
September 22-23, 2016: Bridging Knowledge Gaps to Understand How Zika Virus (ZIKV) Exposure and Infection Affect Child Development (Bethesda, MD), hosted by the National Institute of Child Health and Human Development and the Office of Research on Women's Health, NIH - due to limited space, early registration is recommended
April 10-13, 2017: 27th National Radiological Emergency Preparedness Conference (Grand Rapids, MI) (fee)
For more events, including recordings/presentations from previous events, visit our Events Archive
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 - Additional technical information
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 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
- 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. The Idylla™ Ebola Virus Triage Test should be performed by laboratories in CLIA moderate and high complexity laboratories in the U.S. or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Idylla™ Ebola Virus Triage Test on the Idylla™ System. Additional technical information
- 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
- 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 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 1, 2016: Draft Guidance - Emergency Use Authorization of Medical Products and Related Authorities (Federal Register notice) - comment by June 3, 2016
- December 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.
- FDA issued a PAHPRA question and answer document (PDF, 762 KB) in 2014 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
July 6, 2016: Draft Guidance - Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (PDF, 499 KB) (Federal Register notice) - Also see: FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests and Precision Medicine - On July 27, 2016, FDA will host webinars on these draft guidances: Technical and Regulatory Aspects (12:00 - 1:00 p.m. ET), and Implications for Patients and Providers (1:30 - 2:30 p.m. ET)
July 1, 2016: Guidance - Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (PDF, 174 KB) (Federal Register notice)
June 21, 2016: Final Guidance - Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices (PDF, 696 KB) - On August 8, 2016, FDA will host a webinar on this guidance, which provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device exemptions (HDEs) and de novo requests. It also facilitates continued efforts to address unmet medical device needs for pediatric patients.
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 13, 2016: Draft Guidance - Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers (PDF, 1.4 MB) - comment by August 11, 2016 (Federal Register notice)
- May 10, 2016: Draft Guidance - Technical Considerations for Additive Manufactured Devices (PDF, 548 KB) - This draft guidance provides FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3D printing. Comment by August 8, 2016. More about 3D printing of medical devices
- May 3, 2016: Draft Guidance - Special Protocol Assessment (PDF, 640 KB) - SPA is a process in which sponsors may request to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal trials to determine if they adequately address scientific and regulatory requirements. This draft guidance revises the guidance for industry Special Protocol Assessment issued in May 2002. After it has been finalized, this guidance will replace the May 2002 guidance. Significant changes from the 2002 version include: clarifying which protocols are eligible for SPA; adding animal rule efficacy protocols intended to support approval under 21 CFR part 314, subpart I, and 21 CFR part 601, subpart H, for drugs and biological products, respectively; adding protocols intended to support approval of a biosimilar biological product; providing greater detail about the content of an SPA submission; and clarifying the process for rescinding an SPA agreement.
- April 22, 2016: FDA is announcing a 2-day public hearing September 12-13, 2016 to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and extending the comment period for these documents to September 27, 2016.
- April 18, 2016: Final Guidance - Radiation Biodosimetry Medical Countermeasure Devices (PDF, 514 KB) (Federal Register notice)
- April 1, 2016: Draft Guidance - Emergency Use Authorization of Medical Products and Related Authorities (Federal Register notice) - comment by June 3, 2016
- March 29, 2016: Draft Guidance - Labeling for Biosimilar Products (PDF, 143 KB) - comment by June 3, 2016 (Federal Register notice) - comment period extended to August 2, 2016 (Federal Register notice June 6, 2016) - see also: From our perspective: Biosimilar product labeling
March 11, 2016: Questions and Answers Regarding - Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry (PDF, 310 KB) - FDA issued a new guidance (Q&A) that provides answers to common questions from blood establishments asked in response to guidance issued February 16, 2016, Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry (PDF, 111 KB). Also see Safety of the Blood Supply
- March 9, 2016: Guidance for Industry - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (PDF, 392 KB) (Federal Register notice)
- 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). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues. The new guidance is a part of the FDA’s ongoing efforts to protect HCT/Ps and blood products from Zika virus transmission. (Federal Register notice) (April 12, 2016 Federal Register notice to correct docket number) Also see Safety of the Blood Supply
- View more MCM-related guidance information by topic on our Guidances and Other Information of Special Interest to MCM Sponsors page, or by date on our MCM-Related Guidance by Date page.
- Search all FDA guidance.
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
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.
- 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)
- 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.
- 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.
- April 2015: FDA has posted a new drug shortages infographic
- For a complete list of drug shortages, view our Drug Shortages page or search the Drug Shortages Database
- May 16, 2016: HHS/BARDA has posted a pre-solicitation notice for next-generation anthrax vaccines
- March 29, 2016: NIH posted a funding opportunity, Partnerships for Countermeasures against Select Pathogens. Submit applications by October 3, 2016. More about this opportunity
- 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.
- 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 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 - learn more about BAA funding for MCM-related projects
- 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 10, 2016: The National Science Foundation is accepting research proposals on Zika that address the ecological transmission dynamics of the virus
- October 21, 2015: 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 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
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