Committee Staff Report to the Chairman and Ranking Member

Committee Staff Report to the Chairman and Ranking Member

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6 Once a sponsor addresses the concerns and questions identified in a major deficiency letter, the review team can complete its initial ... In the case of VNS Therapy, the Committee Staff were told that the review team did not believe that the sponsor had ... (3) Training regarding the programming of the device should be provided to primary care providers. (4) The product should have additional patient labeling to inform patients completely of the risks and benefits involved in having theanbsp;...


Title:Committee Staff Report to the Chairman and Ranking Member
Author:
Publisher: - 2006-01-01
ISBN-13:

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