Woodcock's 'Bias' In Sarepta Case Made Jenkins Worry About Future Drug Reviews
In memo to then-Commissioner Califf during review of Sarepta's Exondys 51, Jenkins wrote that he was concerned about leaving OND in hands of CDER director upon his retirement.
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Stakeholders, some worried about "groupthink," tell the US FDA they want the individual discipline comments on newly approved drugs to stay in action packages because of the valuable insights they provide.
Patient advocates asked what they could do after US FDA’s complete response letter for the proposed Duchenne drug, but Sarepta's CEO said the company would get the product back on track to approval itself, a marked contrast to engaged role the community played the last time the firm ran into a roadblock at the agency.