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Political Appointees Shouldn't Influence Approval Decisions, Califf Says

 
• By Derrick Gingery

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, one of the most important issues is the preservation of independence of the FDA as a regulatory and public health agency from the vicissitudes of political influence," Califf said during an Oct

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.