Robert Califf, FDA commissioner (via AP Images)

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDU­FA VII, signed in­to law last Fri­day by Pres­i­dent Joe Biden, the FDA this week un­veiled two new in­dus­try-friend­ly pi­lot pro­grams to ad­vance new rare dis­ease end­points via ad­di­tion­al meet­ings, and to short­en FDA re­view times for sup­ple­men­tal apps aimed at un­met med­ical needs.

The agency this week re­leased ea­ger­ly-await­ed de­tails be­hind the short­ened pi­lot, known as the Split Re­al Time Ap­pli­ca­tion Re­view or STAR pi­lot pro­gram, which will speed up cer­tain FDA re­views of ef­fi­ca­cy sup­ple­ments across all ther­a­peu­tic ar­eas (thanks to ear­li­er sub­mis­sions of da­ta), but on­ly for those that pro­pose ad­dress­ing an un­met med­ical need.

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