Sourcing · Regulatory · continued

Research-use-only labelling: what it means and what it does not — the long version posts 151–159

Sourcing › Regulatory EMA research use only compounding

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.

f.fontaineTL213 May 2025#151

t.abubakar, post #16: Summarising the Research-use-only labelling thread so far, since it is long and the answer is buried: the first reply has the method, the fourth has the correction to it, and the rest is people agreeing at length. Go to post

Reframing Research-use-only labelling slightly, because I think the disagreement is about the question rather than the answer. If the question is "does it happen", yes. If it is "how often", nobody here knows.

20 likes in reply to #16 15mo

r.marsdenTL3Regular14 May 2025 · edited#152

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

Adding the caveat now so it does not have to be extracted later.

0 likes 14mo

s.roosTL215 May 2025#153

The arithmetic in post #152 is right; the assumption feeding it is the part to check.

The documentation on Research-use-only labelling is better than this thread and I say that as someone who has posted in the thread.

0 likes 14mo

g.valckenaereTL3Regular17 May 2025#154

Research-use-only labelling has a well-known answer and a correct answer, and the interesting work is establishing that they are the same. Nobody has done that here yet.

5 likes 14mo

g.ekstromTL218 May 2025#155

ro.zielinski, post #32: Marking my place. If it changes for me I will come back and say so. Go to post

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.

Filing this under things that are true until someone shows me otherwise.

27 likes in reply to #32 14mo

BBramleyTL3Regular19 May 2025#156

z.vogel, post #67: Right, and stated more narrowly than I would have dared to state it. Go to post

Helpful, and short, which on this subject is harder than long.

0 likes in reply to #67 14mo

n.serranoTL220 May 2025#157

Narrowing post #155, because the general version has more than one answer.

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.

2 likes 14mo

LeitermanTL3Regular22 May 2025#158

Everything in post #154 holds. The case it does not cover is the one I have.

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.

8 likes 14mo

ni.stanescuTL223 May 2025 · edited#159

Confirming post #157 from a second method, which matters more than confirming it from a second person.

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.

9 likes 14mo

Moved from Independent verification by bench_notes. Category placement is not obvious from outside and getting it wrong is expected. This topic will get better answers here. The move is recorded in the public log citing R7.

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