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PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors

 
• By Derrick Gingery

A Pfizer exec says that the old prescription drug user fee formulas that usually increase funding and staffing for many FDA programs no longer deliver the same return on investment.

Rolling money uphill
The traditional idea of fixing FDA problems with more staff may be losing efficacy, Emmett said. • Source: Shutterstock

SAN DIEGO – Industry may no longer be willing to accept user fee increases and more hiring as the key to US Food and Drug Administration improvements, a potential change of strategy for handling the prescription drug user fee program.

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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

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Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.

Existing Innovative Trial Design, Endpoint Tools Could Be Help Ultra-Rare Sponsors Need

 
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Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 
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