Here is a good place to start reading and learn about how FDA approvals work.
https://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act
and from the FDA website:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber
https://www.fda.gov/drugs/types-applications/therapeutic-biologics-applications-bla
If you can't find the answer by following these links, perhaps you can find it by searching their website for procedural documents that provide guidance regarding their internal working procedures.
Here is a good place to start reading and learn about how FDA...
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