Priority Review Voucher Fee Decreases For FY 2021 May Reflect US FDA Personnel Changes

In part because assessment costs plummeted in FY 2019, the FY 2021 fee to redeem a priority review voucher will be 37% less than the previous year.

fee decrease
The FY 2021 priority review voucher user fee decreased more than 37% from the previous year. • Source: Shutterstock

Application assessments, among the most labor-intensive US Food and Drug Administration tasks, were substantially cheaper in fiscal year 2019, another indication that experience levels at White Oak may be shifting.

In its announcement of the FY 2021 tropical disease, rare pediatric disease, and

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

More from User Fees

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By 

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

More from Pathways & Standards

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By 

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By 

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.