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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A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.
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