This episode delves into the crucial role of drug labeling, risk management plans, and REMS (Risk Evaluation and Mitigation Strategies) in ensuring safe post-approval drug use. We discuss the essential information contained in drug labels, including dosage instructions, expiration dates, and potential side effects, and how labels serve as evolving safety bulletins that are updated as new information emerges. We explore the proactive nature of risk management plans, which aim to anticipate and mitigate potential risks throughout a drug's lifespan. We also examine the role of REMS as specialized safety protocols for certain medications, including Medication Guides for patients, communication strategies for healthcare providers, and restricted distribution systems. Join us as we unpack the layers of safety built into the post-market drug landscape.