FDA PDUFA Calendar

The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates. These are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.

 

The FDA will typically issue one of the following decisions:

  • CRL - complete response letter - rejection letter noting reasons

  • Marketing approval - approved to market under the given label

 

Sometimes the FDA requires an advisory committee meeting prior to the approval decision. This meeting is a public discussion with committee members of various relevant backgrounds, which usually concludes in a vote regarding the efficacy and safety of the drug in question. The FDA is may use this discussion and vote as a guideline for their decision but by no means are bound to this discussion or vote.

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PDUFA Date

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