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    • Approved Risk Evaluation and Mitigation Strategies

    Metadata Updated: July 11, 2025

    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.

    Access & Use Information

    Public: This dataset is intended for public access and use. License: See this page for license information.

    Downloads & Resources

    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier 6c697267-fe17-4c66-8c6d-da38ab9b723b
    Data First Published 2021-02-25
    Data Last Modified 2013-11-12
    Category FDA
    Public Access Level public
    Bureau Code 009:10
    Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
    Metadata Catalog ID https://healthdata.gov/data.json
    Schema Version https://project-open-data.cio.gov/v1.1/schema
    Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
    Harvest Object Id e333e7d8-ac85-4355-b012-0be959e0f871
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:002
    Source Datajson Identifier True
    Source Hash 44c62dbb60a9f3dab119c4322ac933b1187e1a9815b9b40286c58949a7805845
    Source Schema Version 1.1

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