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CDRH Touts Progress On Clinical Study Reviews

The device center says that the number of review cycles and the median review time for investigational device exemptions dropped ahead of expectations during the past year. Aggressive goals remain for 2015.

FDA's device center says it is well ahead of the goals it set for itself to improve the investigational device exemption review process, but it still has aggressive improvements planned for the current year.

The number of IDE studies that required more than two cycles of review prior to approval dropped by 34 percent...

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