FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies

October 27, 2009

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

The draft guidance for industry titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”:

  • provides FDA’s current thinking on the format and content that industry should use for submissions of proposed REMS
  • describes each potential element
  • includes preliminary information on the content of assessments and proposed modifications of approved REMS
  • describes REMS policies for certain regulatory situations
  • informs industry about who to contact within FDA about a REMS
  • indicates FDA Web sites where documents about approved REMS will be posted
  • provides an example of what an approved REMS might look like for a fictitious product.

Check out for draft guidance at –

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf