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 National Health and Security
In the Headlines
- Save the Date!! MCMi Now Accepting Proposed Session Topics
for its May 29-31 2013 Regulatory Science Symposium
February 12, 2013: FDA Public Meeting of Blood Products Advisory Committee
January 16, 2013: FDA approves new seasonal influenza vaccine developed using new technology
Jan. 2013: Latest Information on Drug Shortages - Oseltamivir Phosphate (Tamiflu) for Oral Suspension
- MCMi awards Regulatory Science grant to Stanford University
- 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 more ...
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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.
Read more ...
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
April 1–5, 2013: Register for FDA Pilot Class on Achieving Data Quality and Integrity in Maximum Containment Laboratories (PDF - 143KB)- Dec. 14, 2012: FDA approves raxibacumab to treat inhalational anthrax!
- Report on FDA’s Medical Countermeasures Initiative Year-2 Program Update – November 2012 Now Available! (PDF - 290KB)
FR Notice: Draft Guidance for Industry and FDA Staff; Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Availability - !!Note: FDA issues Broad Agency Announcement seeking research and development proposals, including for MCMs. This solicitation is open until May 2013.