Topic summary

Coming back to: Research-use-only labelling: what it means and what it does not

Sourcing › Regulatory MHRA personal import research use only Solved

This is a generated summary. It shows the 7 most-liked posts from a topic of 51, in their original order, with the accepted answer included where one exists. It is a reading aid and it will miss nuance — the full topic is the record.

p.silvaTL210 Oct 2024#4

If you can confirm or contradict a position for your own region, please date the answer. An undated regional claim is the least useful thing in this category.

I have no interest in any supplier named above.

29 likes 22mo

i.bakkenTL2 Solution14 Oct 2024#6

dr_okonkwo, post #5: Second-hand on Research-use-only labelling, so weight it accordingly — someone whose method I trust told me this and I have not verified it myself. Go to post

The arithmetic in post #3 is right; the assumption feeding it is the part to check.

Offering a way to settle Research-use-only labelling rather than another opinion about it. Two measurements, taken the same way, a fortnight apart. If the difference is within the noise, the question was not answerable at this precision.

8 likes in reply to #5 21mo

r.venkatesanTL3Wiki editor22 Oct 2024#11

Practical experience of Research-use-only labelling, offered as one case with the conditions stated, not as a general finding. Conditions first, because they are what make it interpretable.

22 likes 21mo

au.pereiraTL229 Oct 2024#16

Post #15 describes the usual case. This is about the unusual one.

An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.

30 likes 21mo

s.kuuselaTL25 Nov 2024#21

maintenance_mode, post #13: Fair, and the limits you put on it are the part I will remember. Go to post

I would call the community position on Research-use-only labelling likely rather than established, and I would be comfortable defending that hedge.

31 likes in reply to #13 21mo

n.moreauTL220 Nov 2024#34

logbook_erin, post #15: An observation about Research-use-only labelling that I cannot explain and am posting anyway, on the principle that unexplained observations are more useful public than private. Go to post

Worth separating two things that post #32 runs together.

Filing a mild objection to the consensus on Research-use-only labelling. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit.

24 likes in reply to #15 20mo

m.ibarraTL226 Nov 2024#39

Adding what did not work for me on Research-use-only labelling, since the failures never get written up and they are half the useful information.

25 likes 20mo

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About the Regulatory categorySourcing › Regulatory · 4 replies

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