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Rare Disease Innovation & Partnership Summit
March 21-23, 2023
Delivered as a Hybrid EventPhiladelphia Marriott Downtown

Janet Maynard
Director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine at U.S. Food and Drug Administration


Dr. Janet Maynard, is the Director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) within the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). In this role, she oversees the development, review, and regulation of applications for drugs and biologic products reviewed within the divisions in ORPURM: The Division of Pediatrics and Maternal Health, the Division of Rare Diseases and Medical Genetics, the Division of Urology, Obstetrics and Gynecology, and the Division of Pharmacology-Toxicology for Rare Diseases, Pediatrics, Urologic and Reproductive Medicine/Specialty Medicine. Prior to serving as Director, she was the Deputy Director of ORPURM.

Prior to ORPURM, Dr. Maynard was the Director of the Office of Orphan Products Development. Before directing OOPD, she worked in CDER. She joined FDA’s Division of Pulmonary, Allergy, and Rheumatology Products in 2011 and then joined the Division of Anesthesia, Analgesia, and Addiction Products.

Dr. Maynard received her medical degree from Vanderbilt University and completed a residency in internal medicine at Duke Hospital. Subsequently, she completed a fellowship in rheumatology at Johns Hopkins Hospital. During her fellowship, she completed a Master of Health Science at the Johns Hopkins Bloomberg School of Public Health in the Graduate Training Program in Clinical Investigation.

Agenda Sessions

  • Navigate FDA Updates on Rare Disease Product Development