Areta L. Kupchyk

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.

 

FDA Regulation of Medical Device Advertising and Promotion

Updated 2018 There are tens of thousands of medical devices being advertised and promoted in the U.S. The Food and Drug Administration (FDA) has statutory authority to regulate the advertising and promotion of “restricted” medical devices as well as any medical devices that are not authorized by FDA for sale or distribution for their intended use. A “restricted device” is a device...

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