1. Pink Sheet
  2. >>Pathways & Standards

US FDA: Please Pay PDUFA Program Fees ASAP

 
• By Derrick Gingery

Carryover funds are limited after the agency's collections schedule was altered by the late user fee program renewal.

Paying an invoice
Program fees generate the bulk of PDUFA revenue for the FDA. • Source: Shutterstock

Even though its user fee programs are renewed, the long wait to complete the process still is causing the US Food and Drug Administration some financial stress.

Agency officials notified sponsors on 7 October that invoices for the PDUFA program fee had been sent the same day. They asked that bills be paid as soon as possible,...

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 User Fees

More from Pathways & Standards

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

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

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

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

 
• By Sarah Karlin-Smith

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.