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News Briefs: FDA Program Alignment Group; CardioMEMS Panel; HCV Coverage Analysis

FDA announces the formation of a new Program Alignment Group, made up of center directors and other officials, and schedules an workshop on intraocular lenses. The agency’s Circulatory System Devices panel will review CardioMEMS’ pulmonary monitoring system again and Medtronic devices. CMS opens coverage analysis for hepatitis C screening. More news.

FDA announced Sept. 6 that it has formed a Program Alignment Group “to identify and develop plans to modify agency functions and processes in order to best achieve mission-critical agency-objectives,” FDA Commissioner Margaret Hamburg wrote in a memo to FDA staff. The group will consist of the acting deputy commissioner for global regulatory operations and policy, the deputy commissioner for foods and veterinary medicine, the associate commissioner for regulatory affairs and acting deputy, and each of the medical product center directors.

“We need to transition to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, well-designed and coordinated implementation and, a de-layered management structure,” Hamburg wrote

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