Janet Maynard MD, MHS

Dr. Janet Maynard, as the Director of the Office of Orphan Products Development (OOPD), oversees legislatively mandated designation and grant programs intended to promote the development of products for rare diseases including, orphan drug, rare pediatric disease, and humanitarian use device designation programs, as well as clinical trial, natural history study, and pediatric device consortia grant programs. In her role, she serves as FDA’s lead in coordinating cross-cutting rare disease issues and engages extensively with patients, sponsors, and other stakeholders. Prior to OOPD, Dr. Maynard worked in the Center for Drug Evaluation and Research (CDER), where she was a clinical team leader in the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP). Dr. Maynard has been with FDA since 2011, when she joined FDA’s Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) as a Medical Officer, before becoming a clinical team leader in DPARP.

At FDA, she has worked with an interdisciplinary team of scientists in evaluating the safety and efficacy of drugs and provided regulatory and scientific guidance to drug developers. She has supported drug development through collaboration with stakeholders in various national and international forums. In addition, she has worked on complex development considerations related to rare diseases, such as rare and serious autoinflammatory diseases. 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.