Avoid Launch Delays By Planning For An FDA-Required REMS

By Melissa Landers

Picture this: The FDA accepts a manufacturer’s NDA, and the manufacturer plans for its impending launch. But shortly before the anticipated approval, the FDA notifies the manufacturer that a Risk Evaluation and Mitigation Strategy (REMS) program is required to market the product.

REMS are FDA-mandated post-marketing safety programs that can be required to appropriately balance a drug’s benefits and risks to support safe use. These safety programs are most often required during the NDA or biologics license application (BLA) process to address risks identified in development.