Political Appointees Shouldn't Influence Approval Decisions, Califf Says

FDA commissioner offers new details about why he left final decision on Sarepta's controversial Duchenne muscular dystrophy drug to FDA's expert bureaucrats.

FDA Commissioner Robert Califf did not want politics interfering with the controversial approval of Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy drug Exondys 51 and decided to stay out of it.

"While it is essential for FDA to be collaborative with the community of patients, advocates, academia and industry during development,...

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