FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: LESSONS LEARNED FROM THE CHEMISTRY, MANUFACTURING, AND CONTROLS DEVELOPMENT AND READINESS PILOT PROGRAM; PUBLIC WORKSHOP; REQUEST FOR COMMENTS

WASHINGTON, Aug. 19 -- Food and Drug Administration has issued a notice called: Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Comments.

The notice was published in the Federal Register on Aug. 19 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual-only public workshop entitled "Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program." This workshop fulfills a commitment in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII) to hold a public...