FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: FDA'S STRATEGY DOCUMENT ON FACILITATING CHEMISTRY, MANUFACTURING, AND CONTROLS READINESS FOR PRODUCTS WITH ACCELERATED CLINICAL DEVELOPMENT

WASHINGTON, July 23 -- Food and Drug Administration has issued a notice called: FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development.

The notice was published in the Federal Register on July 23 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development (Strategy Document), which outlines actions FDA has taken and the Agency's plans for fiscal years 2026-2027 to facilitate chemistry, manufacturi...