The ongoing public health crises of opioid addiction and youth vaping undoubtedly captured significant attention and enforcement resources in 2019, a phenomenon that is unlikely to change as we head into 2020. However, despite the time and energy devoted to these issues, FDA and its partners at the Department of Justice (“DOJ”) nonetheless took significant regulatory and judicial action in 2019 that brought attention to alleged compliance gaps across the medical and health product industries. This year-end enforcement review recaps notable drug, biologic, device and dietary supplement-related enforcement actions and trends in 2019 and discusses likely enforcement priority areas in 2020.
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