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GOOD REVIEW PRACTICES DO NOT REPRESENT "COOKBOOK" APPROACH

This article was originally published in The Tan Sheet

Executive Summary

GOOD REVIEW PRACTICES DO NOT REPRESENT "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. Woodcock maintained that GRPs are "not an attempt to show somebody how to make a specific cake or bake a certain kind of batch of cookies." She said the initiative is "more like a treatise on cooking; the techniques of cooking: how do you beat; how do you fold; how do you whip." Woodcock explained that "it is really going to say why do we do clinical reviews. For example, what are we looking for and how do you go about it."
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