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.
Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials
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.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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