Post #30 describes the usual case. This is about the unusual one.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
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Sourcing · Regulatory · continued
Research-use-only labelling: what it means and what it does not — the long version posts 31–60
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
v.krastev, post #15: What I can speak to on Research-use-only labelling is narrow, so I will keep it narrow rather than generalising from it. Beyond that boundary I do not know. Go to post
Marking my place. If it changes for me I will come back and say so.
Before the thread moves on from Research-use-only labelling — what is the sample size behind the claim? I am not being difficult; I have seen the same figure quoted from an n of four and from an n of four hundred.
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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.
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no.silva, post #21: Narrowing post #18, because the general version has more than one answer. A label change is a regulatory event with a date and a document. Citing the document is what makes a claim about labelling checkable. This is the version I would want a new member to read first. Go to post
Small correction to my own earlier position on Research-use-only labelling. I had the units the wrong way round, which changes the conclusion by an order of magnitude and therefore changes it entirely.
Collapsed as off-topic by two members at trust level 3 or above
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 mechanism is plausible, which is not the same as established.
Confirming post #35 from a second method, which matters more than confirming it from a second person.
Where I have landed on Research-use-only labelling, having got it wrong once in public: the direction is clear, the magnitude is not, and anyone quoting a precise magnitude has borrowed it from somewhere that did not measure it.
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revision_history, post #35: 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. Go to post
I disagree with the framing of Research-use-only labelling above, and I think it is a substantive disagreement rather than a terminological one. Setting out why, so it can be checked.
The reasoning depends on an assumption that is doing a lot of work and is never stated. If the assumption holds, the conclusion follows. I do not think it holds generally.
r.laurent, post #27: Worth stating the null on Research-use-only labelling before we explain it: the observation may be nothing. That possibility deserves a sentence and usually does not get one. 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.
That has been true for the cases I have seen and I have not seen many.
revision_history, post #35: 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. Go to post
Post #40 answers the question as asked. The question underneath it is different.
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.
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.
Written in the hope of being told what I have missed.
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The useful distinction on Research-use-only labelling is between what was measured and what was inferred from it. Both end up in the same sentence and only one of them has error bars.
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r.zielinski, post #23: 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. Go to post
Worth separating two things that post #42 runs together.
Speaking only to Research-use-only labelling as I have actually seen it, rather than as it is usually described: the effect is real, it is smaller than the thread suggests, and the variance between people is larger than the effect.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
Take it as a starting point and not as a specification.
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For anyone finding this later: the short answer on Research-use-only labelling is that it depends on one thing, and the rest of the thread is people identifying which thing.
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Taking post #44 at face value and following it one step further.
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.
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d.szymanski, post #30: Post #26 describes the usual case. This is about the unusual one. Since Research-use-only labelling keeps coming up, it should probably be a maintained page rather than a recurring thread. I am happy to draft it if someone with more direct experience will review it. Go to post
Post #46 and I disagree about the size of the effect, not about the direction.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
Worth saying I have only my own numbers here, and n is small.
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.
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b.oyler, post #37: 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 mechanism is plausible, which is not the same as established. Go to post
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
Posting my Research-use-only labelling numbers with the method attached so they can be discounted properly. Uncontrolled, unblinded, and collected by someone who wanted a particular answer.
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KForsberg, post #4: Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so. The claim is narrower than it sounds, and deliberately so. Go to post
The thing about Research-use-only labelling that took me longest to accept is that a plausible mechanism is not evidence of an effect. It is a reason to look, not a result.
e.lehtinen, post #10: Research-use-only labelling looks different depending on whether you are reading the primary literature or the summaries of it, and the difference is not in our favour. Go to post
A label change is a regulatory event with a date and a document. Citing the document is what makes a claim about labelling checkable.