FDA guideline on BE, draft August 2021 [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2021-08-23 23:46 (31 d 11:31 ago) – Posting: # 22535
Views: 818

Hi Achievwin,

» FDA decided to split BA/BE guidance into two guidance 1) for ANDA filings and 2) for IND/NDAs

Already in 2013/2014.

» More elaborate explanations of each aspect.

I expect to see an update of #2 (current draft of Feb 2019) as well.

Dif-tor heh smusma 🖖
Helmut Schütz
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