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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 speed approval and access to COVID vaccines This “breakdown” of FDA’s “traditional communications techologies,” was even more important than supporting the companies

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