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

 
• By Derrick Gingery

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

FDA Great Room
Will the public be allowed to attend PDUFA VIII negotiations? • Source: Alamy

Sponsors hope that a frequently-asked-questions commitment in the prescription drug user fee reauthorization will speed dissemination of US Food and Drug Administration thinking in the fast-moving cell and gene therapy sector.

As part of the upcoming PDUFA VII renewal, the Center for Biologics Evaluation and Research will publish and regularly update...

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Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
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A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
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The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

More from Pathways & Standards

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?