Wyeth Lawyer On Lessons Of Levine v. Wyeth: Look For Patterns of Risk, Actively Manage The Labeling
Executive Summary
FDA's recent requirement for stronger labeling of Phenergan (promethazine) reinforces the message from the Supreme Court in Levine v. Wyeth that finding a pattern of risk warrants label revisions, according to Wyeth's Chief Regulatory Counsel for Pharmaceuticals Geoffrey Levitt