Why is the FDA developing REMS programs?
The Food and Drug Administration Act of 2007 (FDAA) gave the FDA the authority and responsibility to require drug manufacturers to develop and implement a Risk Evaluation and Management Strategy (REMS) on certain drugs. This is pursued if the FDA determines that a REMS is necessary to ensure that the benefits of the drug outweigh the risks of the drug. Further, Congress has convened hearings to make sure that the FDA is implementing the provisions of the FDAA.
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