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Posted On: 05/17/2020 9:35:51 PM
Post# of 148942
Re: reallypeople? #34305
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
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
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