Approved Risk Evaluation and Mitigation Strategies

Metadata Updated: February 26, 2020

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: No license information was provided. If this work was prepared by an officer or employee of the United States government as part of that person's official duties it is considered a U.S. Government Work.

Downloads & Resources

Dates

Metadata Created Date August 20, 2018
Metadata Updated Date February 26, 2020

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date August 20, 2018
Metadata Updated Date February 26, 2020
Publisher U.S. Food and Drug Administration
Unique Identifier 6c697267-fe17-4c66-8c6d-da38ab9b723b
Maintainer
openFDA
Maintainer Email
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 363ce8b2-3039-4628-81ba-eaa3d7150385
Harvest Source Id 15c538b5-31a0-474e-8ba5-c85ee421cb4d
Harvest Source Title Healthdata.gov
Data First Published 2013-11-12
Homepage URL http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
Data Last Modified 2013-11-12
Program Code 009:002
Source Datajson Identifier True
Source Hash 15263e7d71015702024be1a5da359496837e1174
Source Schema Version 1.1

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