The Prescription Drug User Fee Act (PDUFA) date is the target deadline set by the FDA to complete its review of a new drug application (NDA) or biologics license application (BLA). For biopharma companies, the PDUFA date serves as a critical milestone in the regulatory process and is often used to align commercial launch planning, including manufacturing, sales readiness, marketing, and payer engagement. Approval decisions are typically issued on or shortly before this date.
Source:
Prescription Drug User Fee Amendments. U.S Food and Drug Administration. https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments