Sarepta critic Jenkins is exiting the FDA, and Woodcock takes direct charge of the OND after a painful rupture
A few weeks ago, John Jenkins, the longtime director of the FDA’s Office of New Drugs, caused quite a stir with some advice for biotechs to avoid the same regulatory pathway adopted by Sarepta, the new winner of a controversial FDA approval for Exondys 51 for Duchenne muscular dystrophy.
“Path taken by Sarepta NOT a good model for other development programs,” declared one of Jenkins’ talking points under a final section marked “lessons learned” from eteplirsen and other cases.
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