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

posted by Achievwin – US, 2021-08-23 21:35 (156 d 12:12 ago) – Posting: # 22534
Views: 1,436

» FDA updated the canonical BE guideline for ANDAs. Draft. :-)

Comments period is open till October 22, 2021, Therefore any issues bothering/benefit ANDA folks can be sent to FDA as comments for consideration.

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

More elaborate explanations of each aspect.

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