FDA Proposes REMS Extension in Alternate Drug Review Strategy

The FDA has proposed allowing a four-month extension to the new drug review cycle under an alternative review strategy if a product has a complicated risk evaluation and mitigation strategy (REMS). Industry representatives at a Prescription Drug User Fee Act (PDUFA) reauthorization meeting stated that a REMS with just a communication plan should not require an extension and that use of such an extension should be relatively rare if REMS discussions happen early in the review cycle. As drugmakers and the agency work out details of the PDUFA reauthorization, due in 2012, the agency is considering tossing its current review system and adopting a new model.
Washington Drug Letter