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GOOD REVIEW PRACTICES DO NOT SEEK "COOKBOOK" APPROACH, FDA's WOODCOCK SAYS, BUT COULD SPEED PROCESS BY ALLOWING TRUNCATED NON-PIVOTAL TRIAL REVIEWS

Executive Summary

FDA's Good Review Practices initiative is not an attempt to implement a "cookbook" approach for conducting reviews of NDAs and PLAs, FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a Dec. 6 trade press briefing.
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