FDA Medical Countermeasures Initiative Update
Learn how FDA helps protect the U.S. from emerging public health threats
April 12, 2016 - Today FDA issued the annual Medical Countermeasures Initiative (MCMi) program update report for our fifth year of operations.
FDA continues our ongoing work to advance the development and availability of medical countermeasures to protect against chemical, biological, radiological, and nuclear (CBRN) threats.
This report covers these activities including medical countermeasure-related regulatory science, and legal and policy actions.
Related information
Emergency Use Authorization - New Draft Guidance
| In April 2016, FDA issued a new Draft Guidance for Industry and Public Health Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Although you can comment on any guidance at any time, to ensure FDA considers your comment on this draft guidance before beginning work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016. Related information |
FDA and Brazil cooperate to address Zika virus
On April 11, 2016, FDA and the Brazilian Health Regulatory Agency (ANVISA) issued a joint statement of continued cooperation to address the public health emergency presented by the Zika virus disease outbreak in the Americas.
Related information
- Zika virus response updates from FDA
- Leia a declaração em Português (Read the statement in Portuguese)
News updates
Events:
- New! April 13, 2016: FDA will join other public health experts in a Zika Twitter chat hosted by Reuters, 2:00 - 3:00 p.m. ET, #ReutersZika
- April 13-14, 2016: Public Workshop: Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies(Bethesda, MD and webcast) - the purpose of this workshop is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies
- April 19-22, 2016: Preparedness Summit
(Dallas, TX), hosted by the National Association of County and City Health Officials (NACCHO) (fee) - includes a Medical Countermeasures Link workshop to provide federal updates for state strategic national stockpile and local MCM coordinators. New! FDA will also present at the late-breaking Zika session on April 19.
- May 12, 2016: FDA Grand Rounds - Antibiotic resistance surveillance in the age of genomics: New answers to old questions, presented by Patrick F. McDermott, MS, PhD, FDA Center for Veterinary Medicine
View more events on the frequently updated MCMi News and Events page
In case you missed it:
- 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.
- 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.
- 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 5, 2016)
- HHS blog - Zika and Pregnancy: What You Should Know (April 4, 2016)
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