necessity of retention samples for pilot BE study [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2019-11-25 18:00 (991 d 16:12 ago) – Posting: # 20868
Views: 2,023

Dear Ohlbe,

» As pilot trials are not "required for approval", I would understand that retention samples are not needed for pilot studies. But I'm not a specialist of FDA regulations and John may have a different interpretation.

Thanks! That's certainly one standpoint to look at the regulatory requirement, and it make sense to me. I guess that I missed this point when I read the CFR. Let's see what else we can have in this forum.

All the best,
Shuanghe

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