Areta Kupchyk

Practice Areas

Areta Kupchyk is a partner and Co-Chair of Foley Hoag's FDA Practice Group. She advises biotechnology, medical device, and pharmaceutical companies, as well as health care providers and institutions, researchers, and investors on matters related to the U.S. Food and Drug Administration (FDA). Areta draws on nearly 30 years of experience, including nearly 10 years at the FDA where she served as Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation. She provides clients with nuanced counsel on FDA’s requirements for investigational drug and device products including good clinical practice and FDA pre-submission meetings, as well as FDA requirements after commercialization, including advertising and promotion, adverse event vigilance, Medical Device Reporting, and current Good Manufacturing Practice (cGMP) regulations.

Clients rely on Areta's counsel to identify expedient regulatory pathways to move products to market, including 505(b)2) applications, biosimilars, and De Novo Classifications as well as the traditional NDA, BLA, 510(k) and PMA pathways. During product development and premarket review, Areta helps clients pursue all possible regulatory advantages, such as market exclusivities, orphan and breakthrough therapy designations, exemptions, and priority reviews. For example, Areta has helped clients advance novel products such as cellular and gene-therapies, biologics, in vitro diagnostics (IVDs), pharmacogenomic tests, digital therapeutics and other software as a medical device (SaMD). In addition, Areta counsels extensively on FDA’s regulation of human cell, tissue, and cellular and tissue-based products (HCT/Ps), including current Good Tissue Practice (cGTP), and donor eligibility, and assists clients prepare submissions to the Tissue Reference Group (TRG) and Requests for Designation (RFDs) to the Office of Combination Products (OCP).

Areta has significant experience helping clients manage the tension between marketing imperatives and regulatory responsibilities, ensuring sound reasoning and documentation. When noncompliance is an issue, Areta assists clients develop timely and consequential responses to 483s, Untitled and Warning Letters, and other FDA inquiries. Areta also has keen experience analyzing whether recalls are necessary, facilitating needed recalls, and navigating FDA interactions. Whether a matter involves internal assessments or government investigations, Areta provides pragmatic counsel to help clients maintain the right regulatory footing.

Education: University of Maryland School of Law, J.D. (Order of the Coif), University of Maryland Baltimore County, B.A.