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:
“I never heard of an old man forgetting where he had buried his money! Old people remember what interests them: the dates fixed for their lawsuits, and the names of their debtors and creditors.”
—Marcus Tullius Cicero (106–43 B.C.)