December 6, 2021

Volume XI, Number 340

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December 03, 2021

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COVID-19: FDA Warning Letters Address Fraudulent Products and Failures to Meet EUA Requirements [PODCAST]

In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under applicable FDA Emergency Use Authorizations (EUAs), as well as what manufacturers and health care providers alike can learn from this trend.

Copyright 2021 K & L GatesNational Law Review, Volume X, Number 317
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About this Author

Associate

Kenneth Kennedy is an associate in the firm’s Research Triangle Park office, where he is a member of the health care & FDA practice group. Kenneth’s practice focuses on advising clients on a variety of FDA and health care regulatory matters, including drug, device and cosmetic labeling, advertising and manufacturing, research and clinical trial related issues, state and federal health care fraud and abuse, and state, federal and international data privacy and security. He also regularly assists clients with operational matters including the negotiation of supply chain, manufacturing,...

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