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

posted by dshah  – India/United Kingdom, 2022-09-15 13:09 (669 d 15:42 ago) – Posting: # 23296
Views: 3,057

Hi John!
Below decision tree might help you.
[image]
Regards,
Divyen

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One can show the following: given any rule, however “fundamental”
or “necessary” for science, there are always circumstances
when it is advisable not only to ignore the rule,
but to adopt its opposite.    Paul Feyerabend

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