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 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.
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.
September 12-13, 2012: Public Workshop on Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle
September 6-7, 2012: Public Workshop on Risks and Benefits of Hydroxyethyl Starch Solutions5
August 23, 2012: Public Workshop on Use of Influenza Disease Models for Benefit-Risk Evaluation of Vaccines6
July 24 workshop: Use of Computer Simulation of the US Blood Supply7 in Support of Planning for Emergency Preparedness and Medical Countermeasures
June 21, 2012: the US Public Health Emergency Medical Countermeasures Enterprise issues its 2012 Strategy8
June 19-20, 2012: NIAID/FDA Universal Influenza Vaccines Meeting, Register9 now
June 18, 2012: HHS announces10 new centers to develop & manufacture medical countermeasures
June 5-6, 2012: FDA's 2012 MCMi Regulatory Science Symposium11 (Agenda, Program, Poster Winners)
- FDA ANNOUNCES BAA12, 1-YEAR SOLICITATION FOR R&D TO SUPPORT REGULATORY SCIENCE, INCLUDING FOR MCMS. Summary13 available, See Part 1, Section 7.
- April 27, 2012: FDA approves antibacterial treatment for plague14
- Request for Applications15 available on MCM Devices, part of Medical Device Epi Network
- FDA presents 16on 17Anthrax Preparedness18 at Public Health Preparedness Summit
- FDA issues guidance on postmarket adverse event reporting19 during an influenza pandemic
- FDA Presentation on Regulatory Pathways20 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
21Held by the Strategic National Stockpile - Final Rule22 - FDA permits marketing23 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 ...
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
- September 6-7, 2012: Workshop on Hydroxyethyl Starch at Masur Auditorium, NIH, Bethesda, MD
- September 17-18, Animal Models Workshop, Bethesda, MD
- Sept. 27-28, Public Meeting on MCM Radiation Biodosimetry Devices, Regulatory Science Considerations
- ,,, Note: May 23, FDA issues Broad Agency Announcement seeking research and development proposals, including for MCMs. This solicitation is open for one year.
- March 12-15, 2013, Public Health Preparedness Summit 2013, Atlanta, GA
Contact FDA
Dr. Luciana Borio
Assistant Commissioner for Counterterrorism Policy and Director, Office of Counterterrorism and Emerging Threats