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Drugs

November 28: I have a question about a Risk Evaluation and Mitigation Strategy. At what point is the drug company notified that a REMS is required?

CDER Director's Mailbag

FDA can require a REMS before a drug is approved if we determine that a REMS is necessary to ensure that the benefits of the drug outweigh the risk. In addition, FDA can require a REMS after a drug is approved if we become aware of new safety information and determine that a REMS is necessary to ensure that the benefits of the drug outweigh the risks. New safety information is defined as a serious risk associated with use of the drug since the drug was approved, since a REMS was required, or since the last assessment of the REMS.

Page Last Updated: 07/09/2015
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