CDER - changed their timing from 14 days to 30 days in February 2015.
CBER- current standard operating procedures is 14 days - no change.
Our BLA resubmission is before CBER.
Them's the facts - both arms of the FDA
Clear- specific- unambiguous
I tend to follow the documentation rather than posters.
Does that mean we get an update today ?
NFI
Reg
2023 The Final Countdown, page-34
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