Pros And Cons Of A CMS-FDA Parallel Review Program

Law360, New York (October 21, 2011, 2:42 PM EDT) -- On Friday, Oct. 7, 2011, the Centers for Medicare and Medicaid Services and the U.S. Food and Drug Administration (collectively, the “agencies”) announced they were soliciting nominations from sponsors of medical devices to participate in the agencies’ parallel review pilot program. The agencies officially published a Federal Register notice announcing the program Oct. 11, 2011 (the “notice”), with an effective date of Nov. 10, 2011, although the agencies began accepting nomination submissions Oct. 7.[1]

The agencies are soliciting nominations from “sponsors” — presumably, manufacturers — of...
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