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

posted by Helmut Homepage – Vienna, Austria, 2021-08-24 01:46 (521 d 05:39 ago) – Posting: # 22535
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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.

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