PDUFA’s Fairy Godmother: Woodcock Steps Into Breach As Acting CDER Chief
Faced with the departure of Steven Galson as CDER director just as major new drug safety authorities have been bestowed upon FDA, Commissioner Andrew von Eschenbach has turned to former CDER director Janet Woodcock to provide a practiced hand on the wheel of change until a permanent replacement can be found
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Life After Woodcock: US FDA Drug Center’s Leadership Transition
The elevation of the US FDA’s top drug regulator, Janet Woodcock, to oversee COVID-19 response efforts is being framed a temporary step as part of the crisis response. But it is also a try-out for the most significant leadership transition in drug regulation in the US in a generation.
Former CDER Chief Galson Moving To Amgen
Galson, who went to FDA in 2001 to deal with post-marketing surveillance issues, will arrive in time for Aranesp advisory committee meeting.
Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss
Janet Woodcock's move to become director of the Center for Drug Evaluation and Research illustrates the operational challenges FDA faces: The agency remains deeply committed to its historic bargain with the drug industry to take user fees in order to improve application review, but it is finding it increasingly hard to meet deadlines or to perform any other outside projects