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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