Emergency Preparedness and Response
Resources for You
- FDA's Office of Counterterrorism and Emerging Threats
Pediatric Counter-Terrorism Measures - Information / Guidances of Special Interest to Prospective MCM Sponsors
MCMi Webinars - Vaccines, blood, and biologics: Countering Bioterrorism and Emerging Infectious Diseases
- Qualification Program for Drug Development Tools
- IOM-FDA 2011 cosponsored workshop, Advancing Regulatory Science for Medical Countermeasures Development: Slides, Audio
Medical Countermeasures Initiative (MCMi)

-- Protecting the Nation's Health and Security
MCMi presents:
Regulatory Science Symposium
June 5-6, 2012
The Great Room
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Meeting Information and Registration |
In the Headlines
- April 27: FDA approves antibacterial treatment for plague
- Request for Applications available on MCM Devices, part of Medical Device Epi Network
- FDA presents on Anthrax Preparedness at Public Health Preparedness Summit
- FDA issues guidance on postmarket adverse event reporting during an influenza pandemic
- FDA Presentation on Regulatory Pathways Supporting Development and Approval of Vaccines Formulated with Novel Adjuvant, Phacilitate, Washington, D.C. January 2012
- Notice: Exceptions or Alternatives to Labeling Requirements for Products
Held by the Strategic National Stockpile - Final Rule - FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
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About MCMi
The nation's Public Health Emergency Medical Countermeasures Enterprise identified FDA as one of its most critical components. Strong and dynamic FDA engagement with Enterprise partners will establish clear regulatory pathways for product innovators--based on the most advanced science--and will ultimately accelerate MCM development.
Within FDA's Office of the Chief Scientist, the Office of Counterterrorism and Emerging Threats is responsible for leading the implementation of the Medical Countermeasures Initiative in close collaboration with FDA's three medical product centers--CDER, CBER, and CDRH--and the Office of Regulatory Affairs. More ...
Regulatory Science Symposium
Additional Resources
The Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range National Needs
Issued by the U.S. Department of Health and Human Services, Assistant Secretary of Preparedness and Response, August 2010- FDA Commissioner Margaret A. Hamburg, M.D., Announces the Roll-Out of FDA's Medical Countermeasures Initiative
August 19, 2010 - FDA's Medical Countermeasures Initiative, Fact Sheet (PDF - 196KB)
Biomedical Advanced Research and Development Authority (BARDA)
Contact FDA
Dr. Luciana Borio
Assistant Commissioner for Counterterrorism Policy and Director, Office of Counterterrorism and Emerging Threats








