PDUFA Dates
PDUFA dates are deadlines for the FDA to approve new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA is submitted.
Read more about this topic: Prescription Drug User Fee Act
Famous quotes containing the word dates:
“We do NOT know the past in chronological sequence. It may be convenient to lay it out anesthetized on the table with dates pasted on here and there, but what we know we know by ripples and spirals eddying out from us and from our own time.”
—Ezra Pound (1885–1972)