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?

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.