PDUFA date
The FDA's deadline to act on a New Drug Application — the catalyst date for biotech traders.
Definition
PDUFA (Prescription Drug User Fee Act) dates are FDA's commitment-date deadlines to take action on a drug application. For most NDAs and BLAs, FDA must issue an approval, complete response letter, or extension by the PDUFA date.
The two-business-day window before an Adcomm meeting (when FDA briefing documents drop) is a particularly intense catalyst window for biotech.
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