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FDA "GOOD REVIEW PRACTICES" DRAFT REPORT

This article was originally published in The Tan Sheet

Executive Summary

FDA "GOOD REVIEW PRACTICES" DRAFT REPORT is being prepared by outside consulting firm Christakis, Whitehouse & Associates Ltd., as part of the agency's internal examination of ways to improve the product review process. The draft report is expected to be submitted to the agency by early May. Berwyn, Penn.-based Christakis, Whitehouse is an outside facilitator hired by the agency in December to manage discussions on good review practices. The agency is proposing to implement cross-agency GRP guidelines for reviewers.
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