The PDUFA date refers to the date the Food and Drug Administration (FDA) are expected to deliver their decision whether or not a approve a companies New Drug Application (NDA) or Biologics License Application (BLA).

On the PDUFA date the FDA will either:

- issue approval for marketing.

- issue a Complete Response Letter (CRL) - i.e. rejection letter.

Note that most large cap companies do NOT announce PDUFA dates.

https://www.biopharmcatalyst.com/calendars/pdufa-calendar