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. Areta draws upon 30 + years of experience as an FDA lawyer, including nearly 10 years at the FDA where she served as Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation, to provide clients with nuanced counsel on FDA’s pre- and post-approval requirements.
Clients rely on Areta's counsel to identify the most expedient regulatory pathways to get products to market and to obtain all possible benefits, such as market exclusivities. For example, Areta has helped clients advance breakthrough therapies, including cellular and gene therapies and other personalized medicine products, in vitro diagnostics and laboratory developed tests, or LDTs, and genetic and digital therapeutic devices. In addition, Areta counsels extensively on FDA’s regulation of human cell, tissue, and cellular and tissue-based products, or HCT/Ps, including current Good Tissue Practice (cGTP), Donor Eligibility, and communications with the Tissue Reference Group (TRG), as well as Requests for Designation (RFDs) from the Office of Combination Products.More »