Expedited CMC readiness pilot increases communications between FDA and sponsors

As drug short­ages — for cru­cial drugs for can­cer, AD­HD, and di­a­betes — con­tin­ue na­tion­wide, the FDA is pin­point­ing man­u­fac­tur­ing as an area of crit­i­cal need. To­day, the agency un­veiled more de­tails on a new CMC pi­lot, once float­ed to launch last April. It seeks to help com­pa­nies im­prove their chem­istry, man­u­fac­tur­ing and con­trols readi­ness via ad­di­tion­al in­ter­ac­tions with the agency.

The pi­lot, which will start ac­cept­ing ap­pli­ca­tions on Oct. 3 as an amend­ment to an ac­tive IND, is part of the com­mit­ments that the FDA made un­der PDU­FA VII, which is the user fee agree­ment be­tween in­dus­try and FDA that sub­si­dizes the agency’s re­views, and the pi­lot will run through the end of FY 2027.

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