Updates from FDA’s Office of Prescription Drug Promotion: Standards for Direct-to-Consumer Advertising Read more
Policy and Medicine Compliance Update May 2023 Issue Features: Regulatory Challenges in Diversity in Clinical Trials, Embracing Generative Artificial Intelligence, Novo Nordisk’s Trans-Atlantic Speech Woes, and The Sixth Circuit Tackles the Meaning of Remuneration in Kickback Cases Read more
Policy and Medicine Compliance Update April 2023 Issue Features: DOJ’s updated Evaluation of Compliance Program guidance, and End of COVID-19 Health Emergency What Does that Mean for Compliance Read more
Policy and Medicine March 2022 Issue Features FDA Exclusivity, Baby Powder, and FCA Case Dismissal Read more
REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary — Final Guidance Read more
FDA Social Media Guidance: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Read more
FDA Social Media Guidance: Presenting Risks and Benefits With Social Media’s Character Space Limitations Read more
The Food and Drug Administration Safety and Innovation Act (FDASIA): Summary of GDUFA, MDUFA, BsUFA and Pediatrics Read more