Medical Countermeasures Initiative (MCMi)

-- Protecting the Nation's Health and Security

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MCMi presents: 
 

Regulatory Science Symposium

June 5-6, 2012

The Great Room
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD  20993

Meeting Information and Registration

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In the Headlines

• April 27:  FDA approves antibacterial treatment for plague
• Request for Applications available on MCM Devices, part of Medical Device Epi Network
• FDA presents on Anthrax Preparedness at Public Health Preparedness Summit
• FDA issues guidance on postmarket adverse event reporting during an influenza pandemic 
• FDA Presentation on Regulatory Pathways 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
  Held by the Strategic National Stockpile - Final Rule
• FDA permits marketing 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 ...

 

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Regulatory Science Symposium