US FDA’s Three Review Speeds: Standard, Priority – And Oncology
FDA’s oncology review team likes to do things its own way – and at its own hyper fast pace.
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Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.
Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.
The agency’s quickest approvals include two in 2020 – Gilead’s Veklury and Seattle Genetics’ Tukysa – but two 1990s AIDS drugs are at the top of the list.