What is a PDUFA date? A source-reading guide

Start with the official program

FDA’s PDUFA VII materials describe review commitments for fiscal years 2023–2027. The program includes goals for review performance; a calendar row is not an FDA guarantee that an individual product will be approved.

Read the FDA program materials when you need the governing review commitments rather than a market calendar.

Read these fields together

• Product and sponsor identify the program, but do not identify every application.
• Indication and jurisdiction identify the intended use and reviewing authority.
• NDA is a new drug application; BLA is a biologics license application. A supplemental application concerns a change to an existing authorization.
• Goal date is the disclosed review target. Source date is when the statement was published. Review date is when this publication checked it.

Common calendar mistakes

An advisory committee meeting, a clinical readout, a regulatory submission and a PDUFA goal date are different events. A company saying it expects to submit an application does not establish a goal date. A calendar should not turn “Q1 2027” guidance into a precise day.

This pilot includes exact dates only when the source supplies them. It does not publish approval probabilities, trading forecasts or treatment advice.