GOP senators take issue with FDA's use of draft guidances

05/9/2014 | MassDevice.com (Boston)

Sens. Orrin Hatch, R-Utah, Richard Burr, R-N.C., Lamar Alexander, R-Tenn., and Johnny Isakson, R-Ga., are concerned with the FDA's use of draft guidelines governing drugs and medical devices. The draft guidelines, which are issued for comment purposes only, are "increasingly becoming default FDA policy" and "are not being revised, finalized, or withdrawn in a timely manner," the senators wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.

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