FDA Releases Information on Risk Evaluation and Mitigation Strategies (REMS)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS. The FDA answers questions about Risk Assessment and Management Strategy, click here.

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18 Responses to FDA Releases Information on Risk Evaluation and Mitigation Strategies (REMS)

  1. The style of writing is quite familiar to me. Did you write guest posts for other bloggers?

  2. santosh chandgadkar says:

    Where I can find the draft guidance?

  3. Hi Santosh,

    Please find another blog link which I have posted

    https://abhishekkatiyar.wordpress.com/2009/10/27/fda-issues-draft-guidance-on-risk-evaluation-and-mitigation-strategies/

    It will give the REMS Draft Guidence.

    Regards,
    Abhishek

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