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| Dr. Robert Califf |
Dr. Robert Califf has been nominated as the next FDA commissioner. He became the deputy commissioner for medical products and tobacco in February. Prior to that, he worked at Duke University, where he was a researcher and professor of medicine. He will replace former commissioner Dr. Margaret Hamburg and acting commissioner Stephen Ostroff. But he has to be confirmed by the senate first. "Unless they're looking for a reason to slow this down to score points, he should get relatively quick approval," predicted one federal official. Still, his job will likely become political quickly, for Congress is deliberating on an overhaul of federal life science industry regulations known as the 21st Century Cures Act. The device world will be watching keenly to see if he continues down the path of industry friendly actions established by the head of the agency's device arm (CDRH), Dr. Jeffrey Shuren, who's putting a greater emphasis on speedy decisions. Industry would love if the device arm starts approving products at the pace of the European authorities, but a change that big would certainly require assistance from the new head of the entire agency, likely to be Califf. More