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marzan

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marzan

Re: antihama post# 406548

Monday, 10/04/2021 7:45:29 AM

Monday, October 04, 2021 7:45:29 AM

Post# of 708309
antihama, FDA guidance is silent on whether a rolling BLA has to be disclosed or publicly reported.

https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf
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