Areta Kupchyk is an FDA lawyer who advises biotechnology, medical device, and pharmaceutical companies, as well as health care providers and institutions, researchers, and investors on FDA-related matters. She co-chairs the firm’s FDA Law practice group and is resident in the firm's Washington, D.C., office. Areta draws upon almost 10 years of experience as Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation at the FDA to provide clients with nuanced counsel on FDA’s current views for meeting pre- and post-approval requirements.
Clients rely on Areta's counsel to identify the most viable and expedient regulatory pathways to get products to market and to identify and obtain all possible benefits, such as market exclusivities. When there are no clear pathways to market, Areta helps clients develop strategies to advance new technologies through the FDA review process. For example, Areta has helped clients advance clinical decision-support software, medical mobile applications, LDTs, genetic and digital health devices, cellular and gene therapies, regenerative human tissue, and other personalized medicine products.More »