US FDA User Fees
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US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them
An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. Pink Sheet charts the approval times and first-cycle clearances over the course of the generic user fee program.
New GDUFA Workload Formula Will Not Include Inspections Until FY 2025 Fee-Setting
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.
Ban On US FDA User Fee Spending For Certain Facility Costs Forced Budget Shift
Soon-to-be enacted limitation on user fees means building maintenance and other expenses must be paid with non-user fee dollars. The issue was thought to be a significant operational impediment, but the most recent appropriations bill provided some relief.
EU Ministers Want More Targeted Approach To New EMA Fees
Proposals for a new cost-based fee structure at the European Medicines Agency are to be discussed by EU member state health ministers next week, with calls for more targeted fee rises for specific services on the agenda.
EU Fees Revision A ‘Once-In-A-Generation’ Chance To Solve Resource Challenges
COVID-19 and Brexit have put a great strain on the resources of the EU medicines regulatory system, but the planned review of the EU fee system could produce a system that is more flexible, efficient and better able to respond rapidly to emerging technologies and the needs of health care systems, says EFPIA.
UK Regulator Says April Fee Rise Will Support 'Innovative & Efficient' Service
The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”
FDA Reforms Missed By FDORA Could Find Vehicle In Animal Drug User Fee, Pandemic Bills
The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.
Generic Application Mystery: Few ANDAs Withdrawn To Start FY 2023
In past years, sponsors have pulled ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.
Swedish EU Presidency Promises Action On Pharma Law Revision, EMA Fees & AMR
Health care and medicines are among the priorities outlined by the new presidency of the Council of the EU for the first half of 2023.
US FDA Neurology Drugs Program Gains Boost In FY 2023 Funding Bill Amid Calls To Clarify Development Policies
US FDA gains a nearly 7% increase in non-user fee funding, some of which will go for neurology drug guidance.
New EU Fee System To Give Pharma Firms More Predictability
The publication of a draft EU Regulation governing the fees paid by the pharmaceutical industry to the European Medicines Agency is the latest step in a long process aimed at ensuring that the payment system better reflects the actual costs of the regulatory work carried out or coordinated by the EU regulator.
US FDA Shutdown Plan Decreases Potential Furloughs Again, Thanks To User Fee Carryover Funds
More than 80% of FDA employees would continue working during a government shutdown, which appears unlikely as congressional negotiators announce a ‘framework’ agreement.
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