Areta Kupchyk is a partner with Nixon Peabody LLP who provides counsel to clients on the U.S. Food and Drug Administration (FDA) regulation of drug, medical device, biotechnology, and biologic products. Formerly an Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation at the FDA, Ms. Kupchyk possesses a nuanced understanding of FDA regulatory procedure that allows her to insightfully navigate clients through all phases of product development, review, and approval, including obtaining approvals with market protections such as three-year market exclusivity for new indications requiring clinical studies, five-year market exclusivity for new chemical entities, and seven-year market exclusivity for orphan drugs.
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