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FDA to Run Pilots Designed to Reduce Total NDA Review Time

Beginning in October, the FDA plans to test possible solutions designed to curtail multiple-cycle reviews--but it needs drug developers' help. The agency wants sponsors with fast-track product candidates to volunteer for two pilot programs--part of the Continuous Marketing Application (CMA) initiative--designed to assess both rolling application reviews and earlier, more frequent FDA-industry interactions.

Beginning in October, the FDA plans to test possible solutions designed to curtail multiple-cycle reviews—but it needs drug developers' help. The agency wants sponsors with fast-track product candidates to volunteer for two pilot programs—part of the Continuous Marketing Application (CMA) initiative—designed to assess both rolling application reviews and earlier, more frequent FDA-industry interactions.

In the short-term, the pilot studies may prove beneficial for the agency and sponsors alike: the former gains insights into the value of improving the quality and frequency of communicating...

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