Risk Evaluation and Mitigation Strategies (REMS) and Reaching the Market

Risk Evaluation and Mitigation Strategies (REMS) and Reaching the Market
Publish Date:
July 15, 2014
Authors:
Brian Bollwage, JD, Vice President, Regulatory Affairs

Since 2007, the Food and Drug Administration has had legal authority under the FDA Amendments Act to require a risk evaluation and mitigation strategy (REMS) from manufacturers to ensure that the benefits of drugs and biologics outweigh their risks. Even before then, REMS were initiated as early as 1988 involving special programs to detect adverse events relating to the use of Accutane® (isotretinoin), Clozaril® (clozapine) and thalidomide to name some of the earliest.