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...

What is the Purpose of REMS?

Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications Status: Draft Date: September 2009 Target Audience: Industry sponsors and applicants Laws Referenced: Section 505-1 of the Federal Food,...