What are FDA’s Risk Evaluation and Mitigation Strategies (REMS) designed to manage?

The Risk Evaluation and Mitigation Strategies (REMS) established by the FDA are specifically intended to manage the serious adverse effects associated with certain medications. These strategies are mandated for drugs that have been identified as having potential risks that outweigh their benefits in some patient populations. The goal of REMS is to ensure that the benefits of the drug outweigh the risks, which is crucial for maintaining patient safety.

REMS may involve various components such as communication plans, restricted distribution, patient monitoring, and mandatory training for healthcare providers. By implementing these strategies, the FDA seeks to mitigate the risks associated with the product while still allowing access to patients who may benefit from the treatment.

The other choices touch on important aspects of drug development and marketing but do not align with the primary purpose of REMS, which focuses specifically on addressing patient safety concerns stemming from significant adverse effects related to a drug’s use.