Comment on FDA Did The Right Thing, Mostly

FDA Did The Right Thing, Mostly

BY JOSEPH GULFO--So, what is the lesson? One, no, the FDA did not lower its standards in the approval of eteplirsen – the drug is safe and has biological activity, as well as clinical activity seen in a non-randomized study. Two, the FDA needs to ask its AdComms direct, unambiguous questions that capture their approvability recommendations.

 

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