U.S. flag An official website of the United States government
  1. Home
  2. Emergency Preparedness and Response
  3. Counterterrorism and Emerging Threats
  4. Medical Countermeasures Initiative (MCMi)
  5. MCM Issues
  6. FDA/DoD Collaborations
  1. MCM Issues
Image
Combat medics conduct an exercise at the Marine Corps Training Area Bellows, Hawaii, on Jan. 10, 2018. (U.S. Army photo by Staff Sgt. Armando R. Limon, 3rd Brigade Combat Team, 25th Infantry Division)

Enhanced Engagements for Products Relevant to the Department of Defense (DoD)

Public Law 115-92, enacted December 12, 2017, authorized the Department of Defense (DoD) to request, and the U.S. Food and Drug Administration (FDA) to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. On January 16, 2018, the FDA and DoD announced the launch of a joint program to prioritize the efficient development of safe and effective medical products intended for deployed American military personnel.

Utilizing these expanded authorities, the FDA works closely with DoD’s Office of Health Affairs to better understand the military’s medical needs for deployed personnel; give the highest level of attention to and expedite its review of priority DoD medical products in a manner similar to products under the breakthrough therapy designation; provide ongoing technical advice to DoD to aid in the rapid development and manufacturing of medical products for use by the military; and, take a closer look at products currently under development to determine opportunities to expedite their availability.

On November 2, 2018, FDA and DoD signed a Memorandum of Understanding (MOU) setting forth the framework for the ongoing partnership and the creation of a robust program that can better serve the health care needs of American military personnel.

Related Links

Subscribe

Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases.