Some more info [GxP / QC / QA]

posted by Ohlbe – France, 2021-09-17 20:28 (280 d 18:50 ago) – Posting: # 22587
Views: 3,001

Hi ElMaestro,

» One good question is what happens now. I would not be surprised if PanExcell and Synchron will cease to exist (might pop up under another name?), sponsors using the two CROs will be forced to abandon some/all of their MA's and/or repeat studies

Yes, indeed, in the USA: instructions to companies have now been posted on the FDA web site. Repeat all studies; therapeutic equivalence of already approved products is meanwhile changed to BX. Europe: it should not take them more than a year or two to decide what to do :sleeping:

» Have a look at the pdf files from FDA. Now answer this question: Which day were the letters issued?

» Do we really need to go looking for the date on the linking FDA page?

According to this new page: the letters were sent out on 15 September 2021.

Regards
Ohlbe

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