ANVISA: MD studies no more required [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-07-13 19:03 (198 d 04:03 ago) – Posting: # 23144
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Hi Shuanghe,

❝ I remember that you had given some talks about BE to ANVISA staff before.

Twice – the last one dealing with the necessity of multiple dose studies.
Haha, now I can write it esp. for you: See this article. If you are short in time, go straight to its Postscript.
Even shorter executive summary (for the guy in the Armani suit): Multiple dose studies are no more required for the ANVISA.
In April 2021 a revision of the guideline was promised for the next summer. If there is one, I failed to find it at the ANVISA’s website, as usual.*

❝ Maybe next time you can suggest why they should not request schedule time point :lol3:

Sure. :-D

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