Donna Griebel, M.D. is former Director of the Division of Gastroenterology and Inborn Errors Products (DGIEP) in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). As acting Director, she regulated Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologics Licensing Applications (BLAs) for drugs and therapeutics biologics intended for the treatment and prevention of gastrointestinal, hepatic and nutritional disorders and inborn error of metabolism. In her prior position, Dr. Griebel was Deputy Director of the Division of Reproductive and Urologic products where she oversaw the safety and efficacy of drugs and therapeutic biologics aimed to improving reproductive and urologic health. She has extensive regulatory experience in drug development and served on CDER’s Medical Policy Council (MPC) and the MPC’s Subcommittee on Safety Outcome Trials.