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U.S. Department of Health and Human Services

For Industry

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Director for the Office of Orphan Products Development


Gayatri R. Rao, M.D., J.D., Director for the Office of Orphan Products Development (OOPD) received her M.D. from the University of Medicine & Dentistry of New Jersey - New Jersey Medical School.  Upon graduation from medical school, she went on to earn a joint J.D. from the University of Pennsylvania Law School, where she concentrated on healthcare and FDA related issues, and a masters in bioethics from the University of Pennsylvania School of Medicine.  Following law school, she worked for an international law firm, in Washington, D.C., focusing primarily on food and drug law and other healthcare related matters, including matters related to orphan products.  She then joined the FDA’s Office of the Chief Counsel where she provided advice on a wide range of issues related to medical devices, combination products, clinical trials, and human subject protection.  She has brought her unique medical, legal/regulatory, and bioethical background to help move the OOPD rare disease mission forward.