Risk evaluation and mitigation strategy

Reference no: EM133201107 , Length: 1 Pages

Question

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 included provides a list of REMS that have been approved by FDA. Using the provided hyperlink, how does the submitted REMS compare with what is required in the regulations?

Reference no: EM133201107

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