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US FDA User Fees

Set Alert for FDA User Fees

US FDA’s Standard Application Assessment Makes A Comeback

After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.

User Fees Review Pathway

Preparing For A Shutdown: US FDA To Retain 81% Of Workforce, Thanks Mostly To User Fees

However, user fee carryover balances will not last forever and service cuts are inevitable if a shutdown lingers for several weeks.

FDA Legislation

EU Bodies Agree On Ways To Future-Proof EMA Funding System

EU ministers say that implementing an appropriate fee structure that is more in line with actual costs will promote innovation in the pharmaceutical sector while ensuring “fair access” to safe and effective medicines for patients.

Europe User Fees

The $4 Million NDA: US FDA User Fees After 30 Years

The cost of filing a New Drug Application with the US FDA has pushed above the $4 million mark. That is a remarkable rate of increase from the original $100,000 fee set in 1992 – but it does buy a lot more.

User Fees Drug Review

ANDA Submissions Lagging As FY 2023 Nears Its End

Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.

Generic Drugs Review Pathway

New Workload Categories Add To FDA Staff Needs, Help Increase User Fees

Postmarketing activities, such as REMS document and annual report reviews, are now part of the formula used to account for workload changes in user fee calculations, which likely helped push fees higher in fiscal year 2024.

User Fees Review Pathway

Pharma Will Continue Paying For Last Year’s Inflation Spike With FY 2024 User Fees

Increases in the consumer price index helped drive some of the user fee increases that will take effect on 1 October, even though personnel costs declined in some FDA programs.

User Fees Review Pathway

PDUFA Fees Push Higher In FY 2024, While Biosimilar Fees Race Downward

Fiscal year 2024 prescription drug user fees skyrocket in part because of a low application volume in FY 2022, while biosimilar user fees continue to drop due to the program’s healthy operating reserve.

User Fees Review Pathway

US FDA Hiring Data: CBER Exceeds CDER In Progress Toward Goals

Through three-quarters of fiscal year 2023, CBER had hired nearly 70% of the mandated new PDUFA VII employees, while CDER had only hired 40%. The drug center also hired only 36% of the required new BsUFA III employees.

FDA User Fees

EMA Fee Proposals Pass Another Legislative Milestone

Agreement on a new, more streamlined fee structure for the European regulator could be reached by the end of this year. 

Europe User Fees

US FDA’s Oncology Divisions Have Been Providing Live Meeting Minutes For Years. Will Others Follow?

Oncology division officials summarize the agreements and discussions reached during formal meetings so there are no misunderstandings later. Sponsors want the practice used more widely by the FDA.

Research & Development Review Pathway

US FDA’s Marks Worries Someone May Stop Hybrid Work System

CBER Director Peter Marks said the FDA’s remote and in-person work system is functioning well and continues to help recruitment.

FDA Leadership

Supplemental Filings: House GOP Tries to Ban FDA Pride Flag; Amyloid PET NCD Updates Soon

As the FDA flies the Progressive Pride Flag in honor of Pride Month, an appropriations bill provision would limit the flags that could be flown at it and other federal agency buildings. Plus news on Medicare's amyloid PET NCD, reimbursement for new end-stage renal disease drugs, opioid disposal and what FDA can't use its user fees for in 2024. 

Regulation FDA

EMA Fees: Parliamentary Committee Insists On Full Transparency & Sufficient Funding

The ENVI committee says the regulatory work done by national regulators on behalf of the European Medicines Agency must be properly remunerated to ensure “world-class pharmaceutical supervision."

Europe User Fees

EU Ministers Back Greater Role For Member States In Updating EMA Fees

The Council of the EU has broadly accepted the European Commission’s proposal for a new, cost-based fee and remuneration system, but has suggested giving the European Medicines Agency’s management board – and hence the member states – a bigger role in future fee changes.

Europe Regulation

US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program

With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.

User Fees Research & Development
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