Senate Republicans want answers from FDA commish Hamburg on draft guidances

Senate Republicans want answers from FDA commish Hamburg on draft guidances-massdevice: Four Republican senators are asking FDA commissioner Dr. Margaret Hamburg for some answers on the federal watchdog agency's practice of issuing draft guidances to cover medical device and drug review policies. In the May 6 letter the legislators – Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.) and Orrin Hatch (R-Utah) – say they're concerned that the draft guidances are being used by the FDA "to make substantive policy changes."