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Sourcing · Regulatory · continued

Coming back to: Research-use-only labelling: what it means and what it does not posts 31–51

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1 · go to the accepted answer.

MC
m.coelhoTL217 Nov 2024#31

Appreciated. The plain phrasing does more work here than a longer post would.

0 likes 20mo
BS
b.solbergTL218 Nov 2024#32

A label change is a regulatory event with a date and a document. Citing the document is what makes a claim about labelling checkable.

That is one dataset and I would not build a rule on it.

1 like 20mo
PM
p.mbekiTL219 Nov 2024#33

Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.

I am not the right person to answer the follow-up to this.

11 likes 20mo
NM
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
JS
j.steinerTL222 Nov 2024#35

A label change is a regulatory event with a date and a document. Citing the document is what makes a claim about labelling checkable.

I would be glad to be shown a cleaner way of putting this.

0 likes 20mo
AR
a.reyesTL4 Admin23 Nov 2024 · edited#36

The number people quote for Research-use-only labelling is a central estimate presented without its interval, and the interval is wide enough that the estimate is nearly uninformative on its own.

0 likes 20mo
LS
l.salinasTL224 Nov 2024#37

Picking up post #34: that is the part I would want checked first.

Reading this Research-use-only labelling thread as someone who came in with a fixed view: the third and seventh replies moved me and the confident ones did not.

7 likes 20mo
SL
s.leclercTL4 Moderator25 Nov 2024#38
t.marchetti, post #20: Quietly grateful for the plain phrasing. Not every thread gets that. Go to post

On post #36 — agreed on the reasoning, with one qualification.

Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.

17 likes in reply to #20 20mo
MI
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
MH
ms_hollowayTL4Mass spectrometrist27 Nov 2024#40
k.salinas, post #8: Off-label use and medical practice: clinicians can prescribe approved medications off-label under some circumstances. That is different from research-use-only compounds, which are not approved for any human use. Go to post

Right — I had this wrong and I am glad to have read it before it mattered.

0 likes in reply to #8 20mo
KR
k.redgraveTL2Member28 Nov 2024#41

The most useful thing anyone has posted about Research-use-only labelling in this category was a table of what had been measured and by whom. That is what I would want again.

0 likes 20mo
ZS
z.szaboTL229 Nov 2024#42

Narrowing post #41, because the general version has more than one answer.

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.

18 likes 20mo
CP
citation_peakTL3Regular1 Dec 2024#43

Post #41 and I disagree about the size of the effect, not about the direction.

Off-label use and medical practice: clinicians can prescribe approved medications off-label under some circumstances. That is different from research-use-only compounds, which are not approved for any human use.

I am reporting what happened, not recommending it.

7 likes 20mo
SI
s.ivaturiTL22 Dec 2024#44
a.reyes, post #36: The number people quote for Research-use-only labelling is a central estimate presented without its interval, and the interval is wide enough that the estimate is nearly uninformative on its own. Go to post

I would rather this thread reach "we do not know" about Research-use-only labelling than reach a confident answer that nobody can support when asked.

1 like in reply to #36 20mo
EN
electrolyte_notesTL2Regular3 Dec 2024#45

I read post #41 twice before replying, because I had assumed the opposite.

Research-use-only status is a legal classification, not a safety classification. It means the compound is sold for laboratory use and not for human consumption. The label does not establish whether the molecule is safe, efficacious, or toxic.

0 likes 20mo
ZC
z.cardosoTL24 Dec 2024#46
NT
nl_translatorTL2Translator · NL5 Dec 2024 · edited#47
d.fontaine, post #7: Where I part company with post #3, and it is a narrow parting. Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported. Go to post

A note on scope: what I am saying about Research-use-only labelling applies to the case in the first post and I would not extend it further without checking.

12 likes in reply to #7 20mo
BD
b.dumitruTL26 Dec 2024#48
s.ivaturi, post #44: I would rather this thread reach "we do not know" about Research-use-only labelling than reach a confident answer that nobody can support when asked. Go to post

Useful. I had the fact and not the reason, which turns out to be the important half.

4 likes in reply to #44 20mo
EL
endpoint_lineTL3Regular7 Dec 2024#49

Coming back to post #45, because the follow-up matters more than the original answer.

Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.

A weak preference rather than a position.

19 likes 20mo
ID
i.dumitruTL28 Dec 2024#50

Research-use-only material is not approved for human use anywhere. That is a statement about the material's regulatory category rather than about its quality.

Noting that I have skin in this question and have tried to discount for it.

8 likes 20mo
RA
r.aldana_pharmdTL4Pharmacist9 Dec 2024#51
l.salinas, post #37: Picking up post #34: that is the part I would want checked first. Reading this Research-use-only labelling thread as someone who came in with a fixed view: the third and seventh replies moved me and the confident ones did not. Go to post

Thank you for the correction. I would rather find out here than later.

0 likes in reply to #37 20mo

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