Publications

New FDA Guidance Issued on Risk Information in Prescription Drug and Medical Device Promotion
DechertOnPoint
June 10, 2009

The U.S. Food and Drug Administration’s recent draft Guidance for Industry, “Presenting Risk Information in Prescription Drug and Medical Device Promotion,” represents a comprehensive and detailed overview of the FDA’s approach to reviewing drug and device advertising. This update examines the new guidance, which includes the FDA’s review of the “net impression” of a promotional piece.