FDA: antique of ’93 [Regulatives / Guidelines]

posted by Beholder  – Russia, 2018-06-21 09:21 (1559 d 22:51 ago) – Posting: # 18936
Views: 7,850

Hi Helmut and all!

» Now I know where the Europeans copypasted from.

I went through the forum but still could not find the information. Ok, we know that it is "highly likely" (;-)) that the EMA took "1/10 or 100,000 rule" from FDA. But why did FDA deside to use 1/10 or 100,000 rule? Why not, for instance, "1/15 and 150,000" or 100,000 is just round number and that's all?

Thank you in advance

Best regards
Beholder

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