Jenkins’ Exit Interview: He’ll Miss Insider Status Upon FDA Departure
Outgoing US FDA Office of New Drugs director tells the Pink Sheet being on the outside will take some adjustment.
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A departure date has yet to be determined for the associate director of therapeutic biologics, who helped negotiate and implement the biosimilar user fee program.
Sarepta will face a US FDA staff with which it does not have a controversial history, the Center for Biologics Evaluation and Research, likely avoiding the reviewers that evaluated its Duchenne muscular dystrophy treatment Exondys 51.
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.