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

posted by jag009  – NJ, 2022-09-08 21:32 (86 d 17:24 ago) – Posting: # 23280
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Hi,

❝ You guess it right John.


If you fail f2 comparison between highest and lowest (or other) strengths then they wont grant you the waiver unless you run bio, even if you claim formulations are proportional.

John

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