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Approved Risk Evaluation and Mitigation Strategies

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.

Source: OpenFDATest
FieldValue
Publisher
Modified
2013-11-12
Release Date
2013-11-12
Homepage URL
Identifier
6c697267-fe17-4c66-8c6d-da38ab9b723b
License
License Not Specified
Contact Name
openFDA
Contact Email
Public Access Level
Public
Harvested from OpenFDATest
Harvest Source TitleOpenFDATest
Harvest Source URIhttps://open.fda.gov/data.json
Last Harvest PerformedThu, 01/10/2019 - 00:04