The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.
1. Tobacco: E-Cigarettes Top Public Health, Enforcement Priority
E-cigarettes dominated the headlines throughout 2019. On December 31, 2019, the Trump Administration…
