Significant Regulatory, Compliance, and Enforcement Developments, 2021 STEPHANIE PHILBIN & LAUREN FARRUGGIA*  The COVID-19 pandemic continued to dominate the U.S. Food and Drug Administration’s (FDA or agency) priorities for 2021, with FDA making some substantial regulatory changes, including some spurred by the proliferation of new SARS-CoV-2 viral mutations. Meanwhile, FDA continued to devote significant [...]

2021 Significant Settlements JUSTINE E. LENEHAN* I. Introduction This chapter summarizes a selection of significant settlements in 2021 between members of the food and drug industry and the U.S. Food and Drug Administration (FDA) alongside the U.S. Department of Justice (DOJ). The enforcement authority of FDA and DOJ includes both civil penalties and criminal [...]

Food and Drug Cases to Watch in 2022 JAMES M. BECK, RENE BEFURT, AUGUST T. HORVATH, WILLIAM JANSSEN & GINGER PIGOTT* We asked our Top Cases chapter authors for their picks on which current litigations, regulatory actions, and other developments have the potential to change the food and drug landscape in the balance of [...]