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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Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.
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.