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Gottlieb Unlikely To Make Major Changes Right Away, Former Official Says

 
• By Mark W. Sherman

New US FDA commissioners have a lot of housekeeping to do before they can get to the fun stuff, according to former associate commissioner Wayne Pines.

FDA entrance sign 2016

US FDA Commissioner Scott Gottlieb has used his first weeks in office to signal that the agency will be taking significant steps on drug pricing and the use of opioids. But even as he aims for bold policy changes, at least for a while Gottlieb will be consumed by more prosaic tasks, according to Wayne Pines, health care president at APCO Worldwide and former associate commissioner for public affairs.

“Admittedly, this administration is somewhat more chaotic and somewhat less directive than previous administrations – actually, by far – but...

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Will US FDA’s Leadership Rediscover The Value Of Advisory Committees?

 
• By Michael McCaughan

After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.

More from Agency Leadership

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
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New South Korea Health Minister Vows ‘People-Centric’ Medical System

 
• By Jung Won Shin

In line with new President Lee’s campaign pledges, South Korea's newly confirmed health minister is expected to tackle key issues including a prolonged doctors' conflict, essential drug supplies and R&D support for the industry.

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.