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BioPharmaceutical Clinical Trials Leadership

FDA to Run Pilots Designed to Reduce Total NDA Review Time

Executive Summary

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.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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