FDA – Page 4 – Policy & Medicine

New Report Outlines a Roadmap for Restoring Public Trust in the FDA

FDA Announces Small Entity Compliance Guide on DTC Radio and Television Prescription Drug Advertisements

Comments Praise and Call for Clarification on FDA DAP Draft Guidance

FDA Releases Final Rule for Direct-to-Consumer Prescription Drug Advertisements

FDA Extends Comment Period on SIUU Draft Guidance

FDA Finalizes Guidance on Real World Evidence in Supporting Drug Approvals

OPDP Issues Untitled Letter to Exeltis

FDA Releases Draft Guidance on Unapproved Use Communications from Firms to Health Care Providers

Policy and Medicine Compliance Update October 2023 Issue Features: Complex World of Medical Education, FDA Regulation of Laboratory Developed Tests, FDA Post Marketing Requirements, Distinct Roles of Legal and Compliance and Teva’s Generic Price Fixing Settlement

FDA Issues Draft Guidance on Postmarketing Requirement Non-Compliance