Which government agencies oversee the production of plant-made pharmaceuticals?
Plant-made pharmaceutical (PMP) production is regulated under stringent requirements of the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA). Several agencies within USDA and FDA regulate and monitor PMPs, including USDA’s Animal and Plant Health Inspection Service (APHIS) under the Biotechnology Regulatory Services (BRS), the FDA Center for Biologics Evaluation and Research (CBER), FDA Center for Drug Evaluation and Research (CDER), FDA Center for Food Safety and Applied Nutrition (CFSAN) and FDA Center for Veterinary Medicine (CVM).
