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...