With an FDA career of more than 15 years, Dionna Green, M.D., F.C.P. is an expert in pediatric and rare disease drug development across the medical product lifecycle, including regulatory and clinical strategy, clinical trial design, and application review. She served as Director of the Office of Pediatric Therapeutics (OPT) within FDA’s Office of the Commissioner, providing expertise and oversight for cross-center regulatory policy and programs to advance the development and availability of pediatric drugs, biologics, and devices across therapeutic areas, including rare/orphan conditions.
Before leading OPT, Dr. Green was a reviewer in the Center for Drug Evaluation and Research (CDER), with a focus on pediatric and rare disease indications. She also advised CDER leadership, staff, and industry on pediatric regulations and clinical pharmacology policies and informed related FDA guidance and policy.
Dr. Green held an FDA Commissioner’s Fellowship in CDER’s Office of Clinical Pharmacology, where her research produced significant insights into pediatric drug safety and transplant outcomes, with implications for clinical development and labeling. Prior to her work at FDA, Dr. Green was a clinical pharmacology research fellow with the Center for Drug Discovery at Georgetown University Medical Center.
Frequently sought for her expertise, Dr. Green has served on a number of national and international committees and was recently President of the American College of Clinical Pharmacology (ACCP).
She received her M.D. from Howard University College of Medicine and trained in Pediatric Medicine at the Herman and Walter Samuelson Children’s Hospital at Sinai.