US (or EU) ANDA: Fail f2 but pass BE? [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-09-05 13:16 (626 d 16:59 ago) – Posting: # 23269
Views: 3,091

Hi John!
You guess it right John.
Kindly refer below PSG for example.
[image]
So, if only BE strength is in the focus, there is no need to worry.
Regards,
Divyen

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