Emergency Preparedness and Response
FDA's Medical Countermeasures Initiative (MCMi)
FDA is an agency in the Department of Health and Human Services (HHS). FDA's mission is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and radiation-emitting products. As a member of the U.S. Medical Countermeasures Enterprise, FDA is helping to define and prioritize requirements for public health emergency medical countermeasures; coordinate research and help set deployment and use strategies for MCMs.
FDA has developed a 3-Pillar approach to its MCM initiative:
- Pillar I: Enhance the medical countermeasure regulatory review processes
- Pillar II: Advance regulatory science for medical countermeasure development and evaluation
- Pillar III: Optimize and modernize the legal, regulatory, and policy framework for effective public health response
Past Headlines 2013
- March 25, 2013: Register Now for FDA's BAA Industry Day, March 25, 2013,
where FDA experts will discuss research grant opportunities, including for MCMs, supporting Regulatory Science and Innovation!
- March 22, 2013: FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes
- March 13, 2013: Assistant Secretary Nicole Lurie Statement on the Pandemic and All Hazards Preparedness Reauthorization Act
- 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
Past Headlines 2012
Dec. 14, 2012: FDA approves raxibacumab to treat inhalational anthrax,
the first monoclonal antibody approved using the Animal Efficacy Rule
- Nov. 20, 2012: FDA approves first seasonal flu vaccine manufactured using cell culture technology!
- Nov. 29-30, 2012: Public Workshop on Burkholderia 10.25 CEs Offered!!
- Nov. 15 - 16, 2012: Blood Products and Cellular Therapies – A Symposium on Emergency Preparedness
- Nov. 2, 2012: FDA Anti-Infective Drugs Advisory Committee Public Meeting
- Sept. 2012: Meeting the Challenges of Medical Countermeasure Development, FDA perspectives in recent issue of Microbial Biotechnology.
- Oct. 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 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)
- 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
- FDA permits marketing23 of the first hand-held device to aid in the detection of bleeding in the skull