Learn how FDA facilitates development of and access to MCMs

As we have since the Medical Countermeasures Initiative (MCMi) was launched in 2010, 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, and emerging infectious diseases, like Ebola and Zika. This report covers these activities for fiscal year 2016, including MCM-related regulatory science and legal and policy actions.

Related information

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Zika Update

FDA informs collection establishments of CDC-identified potential increased Zika virus risk to blood and tissue safety in Florida’s Miami-Dade, Palm Beach, and Broward counties

On March 13, 2017, the Centers for Disease Control and Prevention (CDC) announced that based on a retrospective analysis of Zika virus (ZIKV) infections they identified a potential increased risk to blood and tissue safety, including semen, in Florida’s Miami-Dade, Palm Beach, and Broward counties dating back to June 15, 2016. While Miami-Dade County is the only part of Florida currently (July 29, 2016 to present) designated by CDC as an area of active ZIKV transmission for the purposes of blood and tissue safety intervention, people in this part of Florida regularly travel within and between these three counties and may not recognize that they have been in an area of active ZIKV transmission.

This information has been added to CDC’s webpage used to communicate epidemiological information about ZIKV to the blood and tissue collection community.

Related information

EUA amendments

March 6, 2017 - RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)
March 1, 2017 - CDC Trioplex Real-time RT-PCR Assay (CDC)
February 28, 2017 - Zika Virus Real-time RT-PCR Test (Viracor Eurofins)

More information about EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, implemented in November 2016.

Emergency Use Authorization (EUA) banner

Events

New! March 30, 2017: FDA Grand Rounds - Vaccine adjuvants: New ways to evaluate their safety and effectiveness (webcast), 12:00 - 1:00 p.m. ET - CE credits available
April 6, 2017: Public workshop - Emerging Tick-Borne Diseases and Blood Safety(Bethesda, MD) - to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions - register by March 23, 2017
New! April 24, 2017: FDA and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (Silver Spring, MD and webcast) - The goal of this meeting is to provide information and receive comments on the current activities of ICH, as well as upcoming ICH meetings in Montreal, scheduled for May 28 - June 1, 2017. Registration required. Submit comments by May 12, 2017.
April 24-26, 2017: 20th Annual Conference on Vaccine Research (Bethesda, MD), hosted by the National Foundation for Infectious Diseases - includes presentations on development and approval pathways of vaccines to prevent infectious diseases (FDA's Marion Gruber, PhD, is presenting), and evaluating vaccine safety during public health emergencies (fee)
April 24-28, 2017: Achieving Data Quality and Integrity in Maximum Containment Laboratories course
April 25-28, 2017: Preparedness Summit (Atlanta, GA) - FDA's Gregory Measer, JD, will present Beyond the Last Mile: Monitoring and Assessing Medical Countermeasure Use in Response to Public Health Emergencies (fee)
New! May 3, 2017: FY 2017 Generic Drug Research Public Workshop (Silver Spring, MD and webcast) - FDA will hold a public workshop to obtain input from industry and other interested stakeholders on the identification of regulatory science priorities for FY 2018. Register by April 5, 2017.
May 31 - June 1, 2017: FDA Science Forum (Silver Spring, MD) - The Forum will highlight the breadth and depth of cutting-edge science FDA conducts and will demonstrate how FDA's scientific research informs our regulatory decision-making.

In case you missed it

FDA's CBER is seeking post-doctorate and post-baccalaureate fellows to study immune responses following vaccination and viral infection in humans: studies on Ebola, Zika, pandemic influenza & other respiratory viruses. Apply by May 31, 2017.
FDA is establishing a public docket to solicit input on ongoing efforts to enhance mechanisms for patient engagement at the Agency. Submit comments by June 12, 2017.
Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union (EU) - The U.S. and EU completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities - also see: The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond (March 2, 2017)
CDC is seeking nominations for candidates to serve on the Clinical Laboratory Improvement Advisory Committee, which provides scientific and technical advice and guidance on general issues related to improvement in clinical laboratory quality and laboratory medicine to HHS agencies, including FDA. Submit application materials by May 1, 2017.
From NIH - Yellow Fever in the Americas: Current Outbreak Warrants Close Watch(March 8, 2017)
Zika news from NIH Ethical Considerations for Zika Virus Human Challenge Trials (PDF, 1.1 MB) (February 2017 report) and CDC - CDC study estimates 20-fold increase in certain types of birth defects in pregnancies with possible Zika infection compared with pre-Zika years - also see MMWR (March 2, 2017)
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