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FDA Staffing, Resource Gaps Makes Applying COVID Learnings To Other Disease Areas Challenging

 
• By Sarah Karlin-Smith

CBER Director Peter Marks hopes to run pilot programs that could convince Congress or industry to provide more funding that would enable FDA to offer pandemic-level communication with sponsors in 'normal' times.

drycleaners
FDA’s “dry cleaner”-like communications helped speed COVID vaccines to market, Peter Marks said. • Source: Shutterstock

The US Food and Drug Administration “is struggling” to adapt procedures that sped up the development of COVID-19 vaccines to other disease areas due to inadequate resources and staffing challenges, Centers for Biologics Evaluation and Research Director Peter Marks said.

Marks credited FDA’s pivot to providing drug manufacturers with real-time feedback as the top reason the US was able to...

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US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
• By Derrick Gingery

The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
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AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from Agency Leadership

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 
• By Sarah Karlin-Smith

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First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 
• By Bridget Silverman

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.