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Tuesday, 01/16/2018 11:19:34 AM

Tuesday, January 16, 2018 11:19:34 AM

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FDA launches accelerated review program for products needed by DoD

Jan. 16, 2018 11:07 AM ET|By: Douglas W. House, SA News Editor
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.
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