FDA high­lights pri­or­i­ty re­view vouch­ers re­deemed as reau­tho­riza­tion lingers in Con­gress

The FDA this month pub­lished a flur­ry of Fed­er­al Reg­is­ter no­tices ex­plain­ing in­stances when pri­or­i­ty re­view vouch­ers (PRVs) have been re­deemed un­der the rare pe­di­atric and ma­te­r­i­al threat med­ical coun­ter­mea­sure (MCM) PRV pro­grams.

The six no­tices, which his­tor­i­cal­ly have come when a new PRV is grant­ed but not nec­es­sar­i­ly re­deemed, ar­rive as Con­gress has float­ed ideas around, but ul­ti­mate­ly has not reau­tho­rized the MCM PRV pro­gram.

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