FDA Releases Initial Draft Guidance on Risk Evaluation and Mitigation Strategies (REMS): Seeking Input from Stakeholders


The Food and Drug Administration (FDA) announced on September 30 that it has released a draft guidance for industry, titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.” Comments to the draft guidance are due by December 30, 2009, and should be submitted according to the instructions in the Federal Register notice announcing the draft guidance.


FDA gained authority to require REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), effective March 2008. Pursuant to FDAAA, FDA may require applicants to submit a proposed REMS as part of a new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA) where the Agency deems it necessary to take additional steps to ensure that the product’s benefits outweigh its risks. FDA also has the authority to require holders of approved applications to submit a proposed REMS if new safety information becomes available and FDA determines that a REMS is necessary.

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