FDA's Risk Evaluation and Mitigation Strategies (REMS): Effective and Efficient Safety Tools or Process Poltergeist?

The article focuses on the U.S. Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategies (REMS). Topics include the FDA Amendments Act of 2007 (FDAAA), the impact of REMS on the U.S. health care system, and the FDA's use of Risk Minimization Action Plans (RiskMAPS). Information is provided on REMS's impact on New Drug Applications (NDAs).