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FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More

Executive Summary

FDA's device center 'has a lot of work ahead of us,' to implement not only the 21st Century Cures Act, but also maintain performance goals for device and drug reviews, speakers said at a Food Drug Law Institute meeting May 5. The agency released a proposed work plan for use of 'Cures' Innovation Account funds, with dollars detailed for the device side on breakthrough devices, humanitarian device exemptions, and least burdensome device provisions, among others, as spelled out for use at a May 8-9 Science Board meeting.

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