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US FDA User Fees

Set Alert for FDA User Fees

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

With Increasing New Drug INDs Projected, How Much More Workload Can US FDA Handle?

Meanwhile, the biosimilars program is expecting essentially flat application numbers, but more manufacturing supplements and more development meetings, which likely is an indication of the sector’s flourishing in the US.

Review Pathway User Fees

Closing The Books On GDUFA II: How Generics Fared At US FDA Over The Last Five Years

Approval and submission data indicate steady trends aside from one outlier year.

Generic Drugs User Fees

Requiring FDA Guidances Does Not Always Advance The Science, Gene Therapy Director Says

OTAT Director Wilson Bryan says important cell and gene therapy guidances came from clear community needs, not user fee program requirements.

Gene Therapy Guidance Documents

US FDA: Please Pay PDUFA Program Fees ASAP

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

User Fees Review Pathway

Pink Sheet Podcast: Makena Withdrawal Hearing Nears, In-Person Meetings At US FDA, User Fees Released

Pink Sheet reporters and editor discuss new developments in the Makena withdrawal case, FDA taking small steps toward resuming in-person meetings at its headquarters, and the agency finally releasing the FY 2023 user fee rates.

Advisory Committees Drug Review

US FDA's FY 2023 User Fees Finally Revealed

Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.

User Fees Review Pathway

US FDA Begins Implementing New User Fee Programs, But What About The Actual Fees?

Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.

User Fees Review Pathway

After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?

Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.

User Fees Legislation
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