The US Food and Drug Administration Amendments Act of 2007 imparted US FDA the authority to ask for a Risk Evaluation and Mitigation Strategy (REMS) from drug manufacturers so as to make sure that the beneficial effects of a particular drug or biological product outweigh its risks. There are few products which US FDA has approved drugs under the REMS.
One example of REMS could be asking an additional information to be provided with a drug product.
Here are some of the classical examples of products which are approved by US FDA with a REMS
New drug containing enzyme that can lower uric acid level in gout gets US FDA approval
FDA asks GSK to develop Risk Evaluation and Mitigation Strategy for drug Avandai
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