Category: Off-label Promotion

Pacira Files Complaint Calling FDA Marketing Restrictions Unconstitutional

CHC and CCC Launching Regulatory Compliance University for Agencies, Publishers

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

House Energy and Commerce Committee Wholeheartedly Approves 21st Century Cures Act

21st Century Cures Legislation Poised for Full House Committee Vote This Week

FDA Plans for Off-label Communication Draft Guidance, Meeting

PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”