PDUFA Calendar


PDUFA dates for biotech stocks. Advisory Committee Meeting calendar dates also included. 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. 

PDUFA dates and Advisory Committee Meeting dates may also be viewed on the BioPharmCatalyst FDA Calendar. Note that the FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 800 events is available to PREMIUM MEMBERS.

Recent FDA decisions and Advisory Committee vote outcomes are found on the BioPharmCatalyst Historical Catalyst Calendar.

Financial data are delayed 15-25 minutes.

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