F.D.A. Issues Policies to Open Path for Generics

Food and Drug Administration Commissioner Scott Gottlieb, MD, has released new policies to crack down on brand drug manufacturers that try to block the entry of generic drugs to the market.

Brand drugmakers are using FDA Risk Evaluation and Mitigation Strategy (REMS) requirements to block timely generic entry, Gottlieb said. The REMS are required from manufacturers to ensure that the benefit of a drug outweighs its risks.

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