Emergency Preparedness and Response
Resources for You
Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA FDA Medical Countermeasure Authorities 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
Medical Countermeasures Initiative (MCMi)
-- Protecting National Health and Security
In the Headlines
- The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), enacted on March 13, 2013, provides key legal authorities to sustain and strengthen national preparedness for public health emergencies. For more information, continue reading ...
- April 22, 2013: H7N9 Influenza Emergency Use Authorization (Potential Emergency)
On April 22, 2013, FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. CDC will distribute this device to public health- and other qualified laboratories.
- MCMi awards Regulatory Science grant to Stanford University
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 ...
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)
- FR Notice: May 29-31, 2013 Medical Countermeasures initiative Regulatory Science Symposium
- Register Now! May 29-31, 2013: MCMi's 2nd Regulatory Science Symposium.
- !!Note: FDA issues Broad Agency Announcement seeking research and development proposals, including for MCMs. This solicitation is open until May 2013.