This may already have been covered, but I was seeking a written confirmation of the duration for acceptance of resubmission of the BLA, and whether the goal date (PDUFA) was provided as part of the acceptance.
The linked FDA document stipulates within 14 days and yes to the goal date. Thought it may be useful for those trying to validate the process instead of relying on third-hand posts.
SOPP 8405.1 : Procedures for Resubmissions to an Application or Supplement
https://www.fda.gov/media/84417/download
This may already have been covered, but I was seeking a written...
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