FDA/DoD Collaborations

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 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, the 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.

Additional details

• Public Law (PL) 115-92 - information from DoD
• Initial Work Plan for Products Relevant to the Department of Defense (PDF, 115 KB) (January 16, 2018)
• News release: FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel (January 16, 2018)
• News release: FDA and DoD formalize collaboration to advance medical products in support of American military personnel (November 2, 2018)
• MOU Concerning Coordination with FDA Regarding DoD Medical Product Development and Assessment (MOU 225-19-01) (November 2, 2018)

Related links

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