FDA Neurology Clinical Team Leader Departure May Be Mountain Disguised As Molehill
Attention to the departure of neurology reviewer Ron Farkas from FDA has focused on what it means for Sarepta’s eteplirsen application, but there are larger regulatory environment issues that deserve more scrutiny.
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Translarna AdCom Has DMD Experience, But Most Opposed Approval Of Prior Applications
Several members of the Peripheral and Central Nervous System Drugs Advisory Committee meeting looking at PTC' Therapeutics' proposed Duchenne muscular dystrophy treatment also looked at Sarepta's Exondys 51 and BioMarin's Kyndrisa, but most did not vote or comment favorably.
Sarepta Complained To Woodcock About Exondys 51 Review Early And Often
Documents also show that Sarepta officials begged CDER director for approval on multiple occasions prior to the agency's September 2016 decision.
Jenkins' Retirement From US FDA Was Several Years In The Making
Outgoing Office of New Drugs director dismisses speculation that his decision to leave the agency was related to events surrounding Sarepta's controversial Exondys 51 approval.