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FDA-Boston Scientific meeting

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific senior officials "acknowledged FDA's assessment of corporate-wide quality system and device reporting deficiencies" during a Feb. 3 meeting with the agency to discuss a corporate warning letter received by the firm Jan. 26, according to an FDA release (1"The Gray Sheet" Jan. 30, 2006, p. 7). The company, which plans to acquire ICD manufacturer Guidant - itself the target of a recent FDA warning letter - said its "highest priority" is to address the compliance issues by working closely with FDA...
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