Akin to its Breakthrough Therapy program aimed at expediting important new medicines for the general market, the FDA and U.S. Department of Defense (DoD) launch a joint program to support accelerated approval for products deemed essential for diagnosing, treating or preventing serious or life-threatening disease in military personnel.
Current high-priority DoD programs include freeze-dried plasma, cold-stored platelets and cryopreserved platelets.
The agency will issue a guidance document to assist commercial product developers in identifying opportunities to fill unmet medical needs of the military after holding workshops this year.