Sarepta’s Aftermath: FDA Staff Still Working Together, Califf Says
US FDA commissioner and others say they have put disagreements from controversial decision to approve Sarepta’s Duchenne muscular dystrophy drug behind them.
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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.
Pink Sheet’s Drug Review Profile looks at US FDA clinical memos opposing approval of Sarepta's Duchenne muscular dystrophy drug eteplirsen, revealing challenges patient advocates and agency face in transforming patient experiences into hard data that can be used for approvals.
Sarepta says US FDA said ‘no,’ but agency repeatedly urged the company to pursue the approach.