Dr. Gayatri Rao M.D,J.D

Director, Office of Orphan Products Development

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Gayatri R. Rao, is the Director for the Office of Orphan Products Development (OOPD) at FDA. The Office’s mission is to advance the development of promising drugs, biologics, devices, and medical foods for rare diseases. As Director, she oversees a number of programs created to promote the development of such rare disease products, including multiple designation programs – like orphan drug, rare pediatric disease, and humanitarian use device – as well as several multi-million dollar grant programs. In addition, she serves as FDA’s lead in coordinating cross-Agency efforts on rare disease issues, is actively engaged in a number of internal and external collaborations, and oversees the Office’s extensive outreach efforts to patients, sponsors, and other stakeholders.