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.
PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors
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.
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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.
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Amid a push for new incentives, the US FDA’s Kerry Jo Lee, associate director for rare diseases in the Center for Drug Evaluation and Research’s Office of New Drugs, said in an interview with the Pink Sheet that the tools ultra-rare sponsors need already are available.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.