Category: Regulatory/FDA

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

Author of “Pharmaphobia” Says Conflict-of-interest Regulations Are Slowing Medical Progress

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FDA Plans for Off-label Communication Draft Guidance, Meeting

FTC to Industry: Consumer Health Data Subject to Privacy, Security Protections

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

FDA Draft Guidance Describes Framework for Electronic Submission of Promotional Materials

What Does OPDP’s Enforcement Lull Mean?