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FDA Expects To Hire Chief Of Shared Services By July

This article was originally published in The Gray Sheet

Executive Summary

FDA is targeting early July for selection of a candidate to oversee the agency's new Office of Shared Services, which is slated to begin operations by Oct. 1

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FDA News In Brief

MDUFMA pediatric study: Institute of Medicine study mandated by user-fee act to assess adequacy of postmarket surveillance for devices used in pediatric populations will begin after appointment of committee members this fall, according to FDA staffers. An initial committee meeting to discuss the nature and scope of the study is expected to take place early next year. Under MDUFMA, FDA is to report to Congress on the results of the study by Oct. 26, 2006. The device center already has fulfilled pediatric provisions in MDUFMA that required the agency to issue guidance on pediatric clinical trial protections and safety and effectiveness criteria (1"The Gray Sheet" July 28, 2003, p. 14)...

FDA News In Brief

MDUFMA pediatric study: Institute of Medicine study mandated by user-fee act to assess adequacy of postmarket surveillance for devices used in pediatric populations will begin after appointment of committee members this fall, according to FDA staffers. An initial committee meeting to discuss the nature and scope of the study is expected to take place early next year. Under MDUFMA, FDA is to report to Congress on the results of the study by Oct. 26, 2006. The device center already has fulfilled pediatric provisions in MDUFMA that required the agency to issue guidance on pediatric clinical trial protections and safety and effectiveness criteria (1"The Gray Sheet" July 28, 2003, p. 14)...

FDA Strategic Plan: Outsourcing Reviews For One-Third Of FTEs By 2006

FDA will review competitive outsourcing opportunities for certain accounting and clerical services in fiscal 2004

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