1. Pink Sheet
  2. >>Product Reviews

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Product Reviews

More from Pink Sheet

Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
• By Derrick Gingery, Francesca Bruce, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.