Navigating FDA Compliance and Civil Litigation: Strategies for Food and Medical Product Companies

Food and medical product companies must prepare for and respond to Food and Drug Administration inspections. When FDA finds violations of the Federal Food, Drug, and Cosmetics Act, the agency often initiates compliance actions, such as issuing warning letters or seeking judicial enforcement action.

Sometimes, such governmental actions expose FDA-regulated companies to the risk of a different type of litigation — civil litigation by private parties. This webinar discusses these risks and how companies can minimize exposure and strike the appropriate balance in responding to both FDA enforcement and civil litigation.

We will discuss consumer litigation, including product liability and consumer fraud, and how manufacturing, distribution, and labeling issues can lead to litigation. We will also discuss the False Claims Act and its connection to data integrity, good clinical practice, and good manufacturing practice regulation.