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FDA News In Brief

This article was originally published in The Gray Sheet

Executive Summary

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)...

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People In Brief

Medtronic adds government affairs officer: Theresa Doyle joins Medtronic as senior director for government affairs, effective Sept. 20. In her previous post as policy director at Health Care Leadership Council - a coalition of chief executives from all disciplines within the healthcare community - Doyle interacted with government leaders on matters related to health information technology, patient safety, price transparency and health insurance regulatory reform, among other Medicare and Medicaid issues. Doyle's nearly 20-year healthcare policy experience also includes a stint at the BlueCross BlueShield Association as director of legislative policy. She will report to VP-Government Affairs Pete Slone...

Pediatric Guidance Released By FDA In Time To Meet MDUFMA Deadline

FDA's draft guidance on premarket assessment of pediatric medical devices advises that study sites for clinical trials involving pediatric populations have equipment and personnel that can address emergency situations specific to children

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