1. Generics Bulletin
  2. >>Products
  3. >>Generics

New GDUFA Workload Formula Will Not Include Inspections Until FY 2025 Fee-Setting

 
• By Derrick Gingery

Capacity planning adjustment that will help calculate generic drug user fees will not include inspections at first to allow more time for time reporting system implementation.

workload
The new GDUFA capacity planning adjustment will include submissions, amendments, postmarket safety activities and other items. • Source: Shutterstock

Fiscal year 2024 generic drug user fee calculations will incorporate a new workload-based model, but not account for all of the categories initially expected.

The US Food and Drug Administration committed to incorporating a capacity planning adjustment into GDUFA III fee calculations as part...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Generics

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By Dean Rudge

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Wockhardt Pivots To Biosimilar Insulins Focus As It Confirms US Generics Exit

 
• By Dean Rudge

Wockhardt is exiting the US generics market through voluntary liquidation of its loss-making US subsidiaries to double down on innovation and focus on antibiotics and biosimilar insulins.

More from Products

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Wockhardt Pivots To Biosimilar Insulins Focus As It Confirms US Generics Exit

 
• By Dean Rudge

Wockhardt is exiting the US generics market through voluntary liquidation of its loss-making US subsidiaries to double down on innovation and focus on antibiotics and biosimilar insulins.

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By Dave Wallace

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.