FDA Picks 3 Kidney Devices For Fast-Track Approval Program

Law360, New York (April 9, 2012, 5:34 PM EDT) -- Three potential breakthrough products for patients with kidney disease have been selected for participation in a new, streamlined approval process, the U.S. Food and Drug Administration announced Monday.

The devices were among nearly three dozen treatments for end-stage renal disease that were submitted to the FDA for inclusion in the Innovation Pathway program, a fast-track framework that debuted last year and looks for game-changing technologies.

Innovation Pathway aims to speed up approvals by lending the FDA’s ear to manufacturers when they’re just beginning to develop products....
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