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By Bambi Grilley, RPh, CCRC, CCRP, CIP, RAC Director, Early Product Development and Clinical Research Center for Cell and Gene TherapyBaylor College of Medicine HoustonTX, USAApprovals and consultation updates from Heath Canada and the Food and Drug Administration for the period April 2021 to May 2021. This Watchdog update focuses on the Update to Regenerative Medicines policy from the US FDA. In November 2017, the FDA released a regenerative medicine policy framework intended to facilitate development of regenerative medicine therapies. At that time the FDA also indicated that they intended to exercise enforcement discretion for certain regenerative medicines in order to give manufacturers and the agency time to determine what requirements would apply. The original enforcement discretion period (EDP) was to expire in November 2020 but was later extended through May 2021. That EDP has now expired...