The immediate impact of the US Food & Drug Administration’s oncology advisory committee’s consideration of six “dangling” Accelerated Approvals in the PD-1 class – and the underlying message that FDA was getting serious about AA drugs that had failed confirmatory studies – was for a sponsor to volunteer to remove an indication from the market.
Pazdur’s Post-Mortem On ‘Dangling’ Accelerated Approvals: Message At ODAC Was Heard Loud And Clear
The three-day advisory committee was intended to ‘put companies on notice’ about the importance of confirmatory trials. The result? Mission accomplished.
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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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