Food And Drug Administration (FDA)

REMS stands for risk evaluation and mitigation strategy.

The Food and Drug Administration (FDA) governs the REMS program. The purpose is to provide drug safety information to the public to improve transparency and communication. The manufacturer is required to disseminate information to be sure that patients are aware of both the benefits and risks of drugs.

This program was initiated in accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Below are two websites that list the REMS strategies and give further information on REMS:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm