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FDA May Not Implement User Fee Workload Adjuster In PDUFA VI

 
• By Derrick Gingery

Three-to-five year timeline needed to develop algorithms does not engender confidence that new version of formula, which historically pushed user fee rates higher, will be ready before PDUFA VII begins.

Close up of blackboard for coaching tactics and strategies

A new resource capacity adjustment method that could significantly impact the user fees paid by sponsors may not arrive before the end of PDUFA VI.

A report commissioned by the US FDA lays out the tasks required to create the necessary infrastructure and produce...

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US FDA’s Latest Review Of Stealth’s Elamipretide Will Move With Speed

 
• By Kevin Grogan

The agency is expected to give its final verdict on the Barth syndrome drug by the end of September. Stealth is seeking accelerated approval based on the path forward outlined in the FDA's May 2025 complete response letter.

Project Orbis: Annual UK Approvals Down Since 2022, But MHRA Touts Advantages

 
• By Eliza Slawther

The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 
• By Sarah Karlin-Smith

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

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EMA Learns Hard Lessons From US-Inspired Streamlining Pilot

 
• By Vibha Sharma

The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.

UK Drug Pricing Scheme Talks Collapse: Industry Braces For Another Year Of High Rebates

 
• By Eliza Slawther

Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.

US FDA Suspends Valneva’s Ixchiq Based On Four New Serious AE Reports

 
• By Sue Sutter

After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.