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 it 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 2012
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)
- 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