Approved Risk Evaluation and Mitigation Strategies

Description

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

Resources

Name Format Description Link
33 ucm111350.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Tags

  • cder
  • rems

Topics

Categories