111 – REMS and Risk Mitigation Strategies (S8E6)

This episode focuses on Risk Evaluation and Mitigation Strategies (REMS) and their crucial role in ensuring drug safety post-approval. We explore how REMS programs are developed, implemented, and monitored, highlighting key components such as ETASU (Elements to Assure Safe Use), communication plans, and monitoring requirements. The discussion emphasizes the collaborative effort between regulators and industry in designing and executing these programs.Real-world cases are used to illustrate the practical application of REMS. The episode examines the challenges of compliance and effectiveness in risk mitigation. The main goal is to explain how REMS serves as an additional layer of safety for medications with known or potential serious risks.