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US FDA User Fees

Set Alert for FDA User Fees

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.

User Fees Legislation

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.”

Europe United Kingdom

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.

User Fees Legislation

Generic Application Mystery: Few ANDAs Withdrawn To Start FY 2023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ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.

Generic Drugs Review Pathway

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.

Europe Legislation

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.

FDA Legislation

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.

Europe Regulation

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.

User Fees Legislation

US FDA Collects ‘Majority’ Of PDUFA Program Fees After Payment Plea

The revenue is expected to sustain the prescription drug user fee program moving forward after reserves were tapped at the start of fiscal year 2023.

User Fees FDA

US FDA’s New Acting Generics Chief Relearning System After 24 Years Of Experience

Acting OGD Director Susan Rosencrance says in an interview that the generics assessment system has evolved substantially since she moved to the Office of Pharmaceutical Quality in 2015.

Generic Drugs Leadership

RWE Program Offers Sponsors Chance At Novel Uses, But In Exchange For Disclosing Proposals

The disclosure requirement to participate includes an option for the US FDA to include the ideas on new regulatory uses for real-world evidence in a guidance or speak about them at public forums in order to ‘promote innovation.’

Real-World Evidence Clinical Trials

US FDA User Fee Staffing: The Objective Capacity Planning Adjuster Often Needs Subjective Review

The FDA has overruled the results from its own formula intended to match resource levels with workload every time except once.

FDA User Fees
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