Sarepta Complained To Woodcock About Exondys 51 Review Early And Often
Documents also show that Sarepta officials begged CDER director for approval on multiple occasions prior to the agency's September 2016 decision.
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One of the faces of FDA's effort to recruit senior leaders from outside its walls has decided to return to industry.
US FDA's Peripheral and Central Nervous System Drugs Advisory Committee to consider application, which PTC Therapeutics filed over protest.