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US FDA User Fees

Set Alert for FDA User Fees

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

Real-World Evidence Under Consideration For Use In Interchangeable Biosimilars Applications

US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.

Biosimilars User Fees

BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals

Six supplement categories based on submission content will be created with review goals between three and 10 months.

User Fees Biosimilars

A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created

Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.

User Fees Manufacturing

Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion

Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.

User Fees Drug Safety

US FDA’s Stein ‘Excited’ About Real-World Evidence, Rare Disease Endpoint Pilot Programs

Head of Office of New Drugs highlights programs being established under PDUFA VII that could help overcome obstacles in drug development.

User Fees Real-World Evidence

PDUFA VII’s Big Commitments: ‘Goal Inflation’ Accelerates

Latest iteration of the Prescription Drug User Fee Act agreement negotiated by US FDA and the pharmaceutical industry continues the trend to ever larger sets of goals and commitments as part of the reauthorization process.

User Fees Drug Review
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