The FDA revealed the first nine recipients of its Commissioner’s National Priority Vouchers, selecting a mix of investigational drugs, approved-abroad products and generics to test a two-month or faster review pathway. Commissioner Marty Makary’s pilot aims to accelerate decisions on products labeled national priorities, including therapies addressing unmet needs and bolstering domestic manufacturing. The agency expanded the cohort beyond initial expectations and companies awarded vouchers now have an expedited regulatory route that could shift development timelines and market entry strategies. Industry observers note the pilot will create case studies on whether compressed reviews affect dossier quality, sponsor–FDA interactions and post-approval obligations.
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