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

posted by Rayhope  – India, 2022-09-15 17:13 (145 d 06:13 ago) – Posting: # 23298
Views: 1,289

❝ Below decision tree might help you.

[image]


HI Divyen ,
Please let me know from where u got this flow chart. Please name the guidance will be helpfull.

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The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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