cannula_trace, post #60: Adding thanks rather than a view. I do not have a view worth the space. Go to post
Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
Sourcing · Regulatory · continued
Research-use-only labelling: what it means and what it does not posts 61–90
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
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.
That holds under the stated conditions and I have stated them.
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Labelling and intended use: a compound sold as "research-use-only" does not change its pharmacology if ingested. It changes the legal status of the sale. The labelling tells you the intended use, not the actual use people make of it.
I looked this up rather than remembered it, which is the right order.
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Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
It is the sort of thing that seems obvious in retrospect and was not at the time.
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ar.kravchenko, post #44: On research-use-only labelling I would separate what is worth knowing from what is worth acting on. The first list is long and the second is short, and conflating them is how threads get heated. Go to post
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.
That has been true for the cases I have seen and I have not seen many.
h.castellanos, post #53: On post #49 — agreed on the reasoning, with one qualification. Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported. I have left out the parts I could not verify. Go to post
This follows post #66 rather than contradicting it.
An update on my earlier research-use-only labelling post: the pattern held for another six weeks and then stopped, which I did not predict and cannot explain.
o.nyberg, post #69: This follows post #66 rather than contradicting it. An update on my earlier research-use-only labelling post: the pattern held for another six weeks and then stopped, which I did not predict and cannot explain. Go to post
Worth separating two things that post #68 runs together.
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.
I would be cautious about generalising from the research-use-only labelling example above. It is a good example. It is one example.
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Post #72 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.
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Adding the measurement that post #72 says would settle it.
Two sentences on research-use-only labelling and then I will stop, because the rest is speculation and the thread is better without mine.
What is documented is narrow. What is inferred from it is broad. The gap between them is where every argument here lives.
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integrator_log, post #72: I would be cautious about generalising from the research-use-only labelling example above. It is a good example. It is one example. Go to post
Clear enough that I do not think I have a follow-up, which is unusual.
bench_peak, post #56: Research-use-only labelling sits at the boundary between what this community can usefully discuss and what it cannot, and I think it falls on the discussable side, narrowly. Go to post
Post #74 is right about the mechanism and I think understates the practical bit.
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.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
That holds for the case as described. Change the assumptions and it may not.
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Building on post #79 rather than restating it.
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.
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ar.petrov, post #65: Post #62 is the version of this I will quote in future. One addition. Research-use-only labelling has been discussed here with more heat than it deserves, mostly because two definitions have been in play the whole time. Go to post
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.
The bit of research-use-only labelling that nobody enjoys is that the answer changes depending on what you are trying to decide with it. Say what the decision is and the thread will converge.
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Understood, and I withdraw the assumption I opened with.
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n.torrence, post #40: Post #39 is right about the mechanism and I think understates the practical bit. 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. Worth checking against a second source before it gets quoted onward. Go to post
Labelling and intended use: a compound sold as "research-use-only" does not change its pharmacology if ingested. It changes the legal status of the sale. The labelling tells you the intended use, not the actual use people make of it.
That has held every time I have looked, which is not the same as always.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
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I have three months of notes on research-use-only labelling and the honest summary is that the trend is real and the week-to-week numbers are noise. I nearly drew the opposite conclusion from the first fortnight.
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s.vogel, post #51: An honest declaration on research-use-only labelling: I have a prior here and it is strong enough that you should weight what I say downward. Stating it rather than hiding it. Go to post
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.
peak_purity, post #2: Answering the research-use-only labelling question as asked, then the question I think is meant. As asked: yes, with the qualification below. As meant: it depends on how the first measurement was taken. Go to post
Post #88 answers the question as asked. The question underneath it is different.
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 not the right person to answer the follow-up to this.
t.steenkamp, post #22: Post #20 and I disagree about the size of the effect, not about the direction. The claim about research-use-only labelling upthread is stronger than its source supports. I have read the source. The source says "associated with" and the post says "causes". Go to post
I read post #86 twice before replying, because I had assumed the opposite.
Research-use-only labelling: I would want to see the raw numbers rather than the summary before agreeing. Summaries lose exactly the information that would settle this.