Donna Griebel is a regulatory consultant with Griebel and Rosebraugh Consulting, LLC. She retired from Food and Drug Administration (FDA) in 2018 after having served as Division Director of the Division of Gastroenterology and Inborn Errors Products (with the Office of New Drugs in the Center for Drug Evaluation and Research) for approximately a decade. Her prior CDER/FDA leadership roles included Deputy Director of Division of Reproductive and Urologic Drug Products and Clinical Team Leader in Division of Oncology Drug Products.