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CDER Hiring Is Booming: Flexibility Of Remote Work During Pandemic Helps Drive Numbers, Cavazzoni Says

 
• By Kate Rawson

Employment totals have also been aided by a (surprisingly) low attrition rate during the pandemic and CDER’s full use the ‘Cures’ authorities; 20% of CDER’s workforce has been hired under Cures.

This is not how FDA actually recruits. It's a photo illustration.
This is not how FDA actually recruits. • Source: photo illustration/Alamy images

The Center for Drug Evaluation & Research’s ability to recruit and retain talent has improved during the COVID-19 pandemic as the US FDA’s drug center is able to offer staff the flexibility to work remotely and has “pivoted” to take full advantage of the salary and hiring authorities under the 21st Century Cures Act.

Speaking at an Alliance for a Stronger FDA webinar on 25 May, CDER Director Patrizia Cavazzoni recalled the first time...

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More from US FDA

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

 
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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

 
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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.