FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CHEMISTRY, MANUFACTURING, AND CONTROLS DEVELOPMENT AND READINESS PILOT PROGRAM; PROGRAM ANNOUNCEMENT

WASHINGTON, Aug. 28 -- Food and Drug Administration has issued a notice called: Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement.

The notice was published in the Federal Register on Aug. 28 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing year four of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP). This program facilitates the expedited CMC development of products under an investigational new drug application (IND) based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot progr...