WLF Files Citizen Petition With FDA To Clarify Off-Label Dissemination
This article was originally published in The Gray Sheet
Executive Summary
FDA violated the terms of a Washington Legal Foundation v. Henney federal appeals court decision when it cited New Star Lasers for dissemination of peer-reviewed articles to doctors, WLF argues in a May 23 citizen petition to the agency.
You may also be interested in...
Disclaimers Do Not Remedy Content Violations – FDA Warning Letter
Providing disclaimers for material that promotes an uncleared or unapproved use does not remedy content violations, FDA's device center Promotion and Policy Staff emphasize in a Nov. 5 letter to Diomed
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.