Leadership

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Timothy Cote, MD

Dr. Timothy R. Coté is a leading national regulatory expert in orphan drug development, and served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept 2007 – May 2011. In this role he implemented the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications. Dr. Coté is founder and CEO at Cote Orphan and has 23 years of federal service at the FDA, NIH, and CDC.