FDA Enforcement and Related Litigation: Responding to FDA and Minimizing Criminal and Civil Litigation Risk

What should a company do after it receives adverse FDA inspection observations or otherwise faces FDA enforcement?

This webinar outlines the types of FDA enforcement actions, agency considerations for taking action, and ways companies should engage with FDA and try to avoid more serious enforcement, to include Justice Department civil litigation and criminal investigations. Since a company's initial response to an inspection or other FDA compliance issue can increase or reduce legal risk in other settings, we will also outline the risks from private litigation that often accompany FDA enforcement, such as mass tort actions and civil False Claims Act suits.

Finally, we address the Biden-Harris Administration enforcement agenda and policy trends in this area.