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. 21, 2012: FDA expands Tamiflu's use to treat children younger than 1 year

• 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. 14, 2012: Vaccines and Related Biological Products Advisory Committee Public Meeting
• 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 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)  

• 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