'The Basics of FDA Enforcement Actions,' by James Fraser and Krupa Patel

[Editor's note: James Fraser is a former Associate Chief Counsel for Litigation at the U.S. Food and Drug Administration (FDA) and is a Senior Counsel in the Product Liability and Life Sciences practice groups in Thompson Hine LLP’s Washington, D.C. office. He also is a member of the International Association of Defense Counsel. His practice is focused on FDA-related litigation and regulatory matters. He is one of the very few product liability defense attorneys in the United States who has worked at FDA. He can be reached at [email protected].

Krupa Patel is a Managing Associate in the Business Litigation, …