Areta Kupchyk is regulatory lawyer representing biotechnology companies at all stages of development and commercialization on Food and Drug Administration (FDA) matters. She currently co-chairs the FDA practice at Foley Hoag LLP in Washington, D.C. Areta began her 30-year career serving at FDA in the Office of the Chief Counsel. During her 10-year tenure at FDA, Areta served as Assistant General Counsel for Litigation and, subsequently, as Associate Chief Counsel for Drugs and Biologics. Areta has extensive experience with pre- and post-market regulatory requirements, such as investigational new drug applications (INDs), clinical trials, breakthrough designations, market exclusivities, compliance with current good manufacturing practice regulations, advertising and promotion, and interactions with healthcare providers. Areta is the author of numerous articles, including two important chapters in Medical Biotechnology: Premarket and Postmarket Regulation, published by the American Bar Association Section of Science and Technology Law: “Approval of Biotechnology Products for Human Use” and “Federal and State Regulation after Approval.” Areta received her J.D. with honors from the University of Maryland School of Law and was inducted into the Order of the Coif.
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