FDA and Pen­ta­gon forge break­through des­ig­na­tion agree­ment

Fol­low­ing the Pen­ta­gon’s crit­i­cism of the FDA slug­gish­ness in ap­prov­ing a French freeze-dried plas­ma prod­uct, which some have said oth­er coun­tries’ troops have used for years, FDA and the De­part­ment of De­fense’s Of­fice of Health Af­fairs on Tues­day launched a joint pro­gram to pri­or­i­tize the ef­fi­cient de­vel­op­ment of such med­ical prod­ucts.

The frame­work for the pro­gram was es­tab­lished, via H.R.4374, af­ter DoD sought to cre­ate its own re­view path­way where­by it could ap­prove med­ical prod­ucts out­side of FDA’s purview.

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