Two Versions: May 21 & May 24 [BE/BA News]

posted by Obinoscopy  – USA, 2018-07-30 20:41 (787 d 01:16 ago) – Posting: # 19117
Views: 5,879

» But IS variations could be considered an assignable cause for analytical repeats.

Yes it is, but I think there is need to determine assignable cause for IS variations.

» I noticed there are two versions of the guidance on the internet. One is dated May 21, 2018 while the other is May 24, 2018.

» Could it be that the May 24 version is the updated and thus the recommended version to use? Was also wondering what was the modification done :ponder:

I have skimmed through both documents. I did not notice any difference except for a very negligible formatting difference: the May 24 document seemed a bit narrower.

If they are same, I wonder what the FDA did on the document for it to change from a size of 373KB to 386KB. I also wonder why the update if there were no changes made. My pondering continues :confused: :ponder:


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