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PDUFA VII: Will Gene Therapy's Rise Influence Talks?

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.

User Fee Reauthorization Preview 2020
Further co-mingling of funds between US FDA centers may be a topic of the upcoming PDUFA renewal talks. • Source: Pink Sheet illustration

The US Food and Drug Administration's Center for Drug Evaluation and Research could see its dominance of the prescription drug user fee program eroded after the upcoming renewal negotiations with industry.

Many stakeholders who are observing the preparations for the negotiations, which are expected to begin later this year, agree PDUFA VII likely only will include incremental changes. The agency also said that it does not "anticipate any major issues" coming up

Among the potential targets for PDUFA revenue is the Center for Biologics Evaluation and Research, which is dealing with an influx of gene therapy and related applications, another acknowledgement of the increasing

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Keep Talking: US FDA’s Beleagured Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
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Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

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