Category: Regulatory/FDA

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FDA Draft Guidance Describes Framework for Electronic Submission of Promotional Materials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?

Who Says You Can’t Fight City Hall?

PhRMA, BIO, AdvaMed Tell FDA Social Media Guidance Is Lacking, Violates First Amendment

Social Media Master Class Helps Companies Navigate Compliance

Coalition Panel: Data Regulation Focus Shifting from Privacy to Security

CMS Bombarded with Comments Calling for CME Exemption to Remain

Coalition Comment to CMS: Keep CME Exemption Under Sunshine Act