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Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials

 
• By Derrick Gingery

Oncology Center of Excellence Director Richard Pazdur also says that he will not grant an accelerated approval if the confirmatory trial is not underway, even if the product shows safety and efficacy.

Richard Pazdur at Friends of Cancer Research Annual Meeting
OCE Director Richard Pazdur and other agency staff spoke about Project Confirm and other programs during the Friends of Cancer Research Annual Meeting. • Source: Screenshot of internet broadcast

Oncology sponsors soon will better understand the meaning of “ongoing” in the context of a confirmatory trial and the potential barrier it presents to accelerated approval.

OCE Director Richard Pazdur said 14 November that guidance on the meaning of “ongoing” is in development – and he also emphasized that without an ongoing confirmatory trial, an oncology...

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