FDA, DOD release work plan for emergency use approvals . . .

FDA Uses Breakthrough Therapy Policy To Expedite DOD Medical Product Reviews

By Beth Wang / January 16, 2018 at 6:51 PM
Updated Story FDA and the Department of Defense's Office of Health Affairs took steps Tuesday (Jan. 16) to implement a new framework to prioritize development of medical products for use by the war fighter, which will include treating DOD medical development programs as if they have received FDA's breakthrough therapy designation, FDA explains in its newly published work plan. FDA's new program for DOD product approvals initially will fall under FDA's Center for Biologics Evaluation and Research...


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