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marthambles

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marthambles

Re: mouton29 post# 2535

Wednesday, 04/20/2022 3:48:10 PM

Wednesday, April 20, 2022 3:48:10 PM

Post# of 7547
This document (which I assume but don't know to be current) specifies the grounds for refusal to file an NDA or BLA.

https://www.fda.gov/files/about%20fda/published/Good-Review-Practice---Refuse-to-File.pdf
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