Is the FDA's REMS Program Effective?

Introduction Risk Evaluation and Mitigation Strategies (REMS) is a type of safety report designed to monitor any drugs “with known or potential risks.” The report must provide comprehensive data that shows a drug’s benefits outweigh their risks. Each REMS must be...

REMS: The Good and the Bad

What is REMS? REMS or Risk Evaluation and Mitigation Strategies is a process in which the FDA effectively evaluates drugs once they have been introduced into the market. Problems Some argue that a REMS effectively constitutes conditional approval. Depending on the...