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FDA Appoints Coté to Head Orphan Products Development Office


The U.S. Food and Drug Administration (FDA) has named Timothy Coté, M.D., M.P.H., as the new director of FDA’s Office of Orphan Products Development. Dr. Coté will be responsible for promoting the development of products that demonstrate promise for the diagnosis or treatment of rare diseases or conditions.

“We are very pleased to have Dr. Coté rejoin the FDA as the new head of the Orphan Products Development office,” said Janet Woodcock, M.D. deputy commissioner for the FDA. “Tim brings a plethora of experience confronting emerging health issues in the United States and abroad, coupled with a commitment to public service.”

Dr. Coté’s experience ranges from medical epidemiology to clinical research.

Dr. Coté, a captain in the U.S. Public Health Service Commissioned Corps, most recently served as the Centers for Disease Control’s (CDC) country director for the African nation of Rwanda. In Rwanda, he directed programs in HIV/AIDS, malaria and avian influenza, and was responsible for scientific and administrative leadership in patient care and research initiatives. He also oversaw the President’s Emergency Plan for AIDS Relief (PEPFAR) operations in Rwanda. Under his leadership, the numbers of HIV-infected individuals receiving anti-retroviral medications from the United States rose from 20,000 to 55,000 persons.

Early in his career, he was a CDC Epidemic Intelligence Officer at the Maryland Health Department. He also served as a senior federal advisor for CDC at the District of Columbia Health Department. From February 2002 until August 2004 Dr. Coté was the chief of the Therapeutics and Blood Safety Branch in the FDA’s Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology.

Dr. Coté has a bachelor of arts degree in biology and psychology from Syracuse University. He earned his medical degree from Howard University College of Medicine, and a masters in public health from the Harvard School of Public Health. Dr. Coté also volunteers as a general practitioner for the Spanish Catholic Center in Wheaton, Md.


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