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Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows

 
• By Kate Rawson

Oncology Center of Excellence’s ‘Project Confirm’ finds that if a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of three years versus 4.9 years if the trial starts after AA.

Clinical trial
Confirmatory trial status at approval is one of the most important factors in converting an accelerated approval to a full approval, FDA said. • Source: Shutterstock

Data out of the Oncology Center of Excellence’s “Project Confirm” underscore the benefit of drug sponsors starting confirmatory trials before accelerated approval is granted, with an application’s conversation to full approval occurring nearly two years earlier than if the confirmatory studies are not underway at the time of AA.

If a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of...

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• By Bridget Silverman

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
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What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
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Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
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Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.