Emergency Preparedness and Response
Resources for You
National Strategy for Biosurveillance (PDF - 406KB)- Guidances / Other Information of Special Interest to Prospective MCM Sponsors
- Qualification Program for Drug Development Tools
- Vaccines, blood, and biologics: Countering Bioterrorism and Emerging Infectious Diseases
Pediatric Counter-Terrorism Measures MCMi Webinars - FDA's Office of Counterterrorism and Emerging Threats
- 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
In the Headlines
- November 29-30, 2012: Public Workshop on Burkholderia
- November 15 - 16, 2012: Blood Products and Cellular Therapies – A Symposium on Emergency Preparedness
- November 14, 2012: Vaccines and Related Biological Products Advisory Committee Public Meeting
- November 2, 2012: FDA Anti-Infective Drugs Advisory Committee Public Meeting
- Meeting the Challenges of Medical Countermeasure Development, FDA perspectives in recent issue of Microbial Biotechnology.
- October 29 – 31, 2012: BARDA Industry Day - Contracting for Countermeasures
September 27-28, 2012: Public Workshop on MCM Burn Mass Casualty Incident1
September 27-28, 2012: Public meeting, MCM Radiation Biodosimetry Devices, Regulatory Science Considerations2; Registration and agenda information available.
September 19, 2012: The Role of Health Research and Regulatory Agencies in Biosurveillance and Biothreat Preparedness
September 17-18, 2012: Workshop on Animal Models3. Registration and workshop information available in the Federal Register Notice4.
- May 23, 2012: FDA ANNOUNCES BAA12, 1-YEAR SOLICITATION FOR R&D TO SUPPORT REGULATORY SCIENCE, INCLUDING FOR MCMS.
Summary13 available, See Part 1, Section 7. Read past Headlines...
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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.
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Additional Resources
- HHS
HHS Public Health Emergency web page Biomedical Advanced Research and Development Authority (BARDA) 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)
Spotlight
Contact FDA
Dr. Luciana Borio
Assistant Commissioner for Counterterrorism Policy and Director, Office of Counterterrorism and Emerging Threats