FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: POSTAPPROVAL METHODS TO CAPTURE SAFETY AND EFFICACY DATA FOR CELL AND GENE THERAPY PRODUCTS; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Sept. 25 -- Food and Drug Administration has issued a notice called: Postapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Sept. 25 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry." The draft guidance document discusses methods and approaches for capturing postapproval safety and efficacy data for cell and gene ...