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McClellan, Wall Street and Increasing FDA Predictability

Executive Summary

The most encouraging aspect of the series of speeches the FDA's new commissioner, Mark McClellan, MD, PhD, has been giving is not what he says--we've heard most of this before--but to whom he says it: pharmaceutical investors and companies.

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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.

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.

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