lunes, 5 de abril de 2010

Approved Risk Evaluation and Mitigation Strategies (REMS)


Approved Risk Evaluation and Mitigation Strategies (REMS)
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. The table below provides a list of REMS that have been approved by FDA.

open here to see the full-text (large):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

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