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