Wednesday, May 18, 2022

12:00–1:00PM ET

Arnold & Porter Webinar

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Over the last few years, the Justice Department and Food and Drug Administration have stepped up civil and criminal investigations and enforcement of violations of the Federal Food, Drug, and Cosmetic Act. This more active enforcement environment has spanned a wide variety of activities that FDA regulates, including food, medical product manufacturing quality, clinical trials, promotion, and post-market commitments.

In this webinar, we discuss how companies should operate in this environment. We outline compliance and enforcement trends, including the FDA's points of emphasis and its escalation process. We then discuss civil investigations and enforcement actions, including their interface with regulatory enforcement. We also review criminal investigations and enforcement, including the Park doctrine, tips for conducting internal investigations, and privilege and work product.