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US FDA User Fees

Set Alert for FDA User Fees

CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave

A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.

FDA Gene Therapy

US FDA Hoping To Spur More ANDA Pre-Submission Meetings During GDUFA III

The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.

Generic Drugs User Fees

Woodcock Outlines Priorities For Next US FDA Commissioner

Along with the pandemic, user fees, IT upgrades and nutrition issues should be at the top of the list, the acting commissioner said.

FDA Leadership

Cures 2.0 Likely To Push US FDA To Further Embrace Real-World Evidence

Draft legislation, which has a good chance of getting wrapped into the next user fee bill, doesn’t give FDA any new authorities or firm mandates on real-world evidence but should nudge agency to more quickly adapt to using RWE for regulatory purposes.

Real-World Evidence Post Market Regulation & Studies

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Generic Drugs User Fees

She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy

She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.

FDA Leadership

BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency

New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.

Biosimilars User Fees

GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors

Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.

Generic Drugs User Fees

GDUFA III Agreement Will Constrain Fee Revenue Increases

Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.

Generic Drugs User Fees

As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing

US FDA’s priority review voucher fee will decrease again in FY 2022 as the cost of a priority assessment continues to trend closer to the cost of a standard assessment.

User Fees Review Pathway

Bright Spot With Potential Shutdown: More FDA Staff Would Continue Working

Nearly 70% of the FDA workforce would be retained, most from carryover user fee dollars, but potential morale problems loom if government funding runs out again.

FDA Legislation

US FDA Aims To Speed Communications On Cell And Gene Therapy Issues With Q&A Guidance

Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.

User Fees Review Pathway
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