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Latest From Michael McCaughan
Podcast discussion of three broader precedents stemming from US FDA's original Exondys 51 approval.
US FDA allowing Sarepta to seek accelerated approval for follow-on DMD agent – following 'precedent' set by eteplirsen. Now the new challenge is to define exactly what that precedent is.
FDA is getting justifiably high marks for its efforts to accelerate drug development, and the proactive communication approach of Commissioner Gottlieb is a big part of that dynamic. But a drug safety withdrawal could be a sign of trouble ahead, if the perception takes hold that Europe is more proactive when it comes to patient safety.