Sourcing · Regulatory · continued

Reading a regulatory notice rather than an article about it — what changed since posts 31–33

Sourcing › Regulatory research use only MHRA FDA personal import

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

preregisteredTL330 Jun 2025#31

Collapsed as off-topic by two members at trust level 3 or above

I would be cautious about generalising from the Reading a regulatory notice example above. It is a good example. It is one example.

y.rahimiTL22 Jul 2025#32

Date every claim in this subcategory. A regulatory position stated without a date is worse than no claim, because it will be read as current indefinitely.

4 likes 13mo

appeals_deskTL3Regular3 Jul 2025 · edited#33

Adding the measurement that post #30 says would settle it.

Regulatory approval is a decision about a specific product from a specific manufacturer. It does not travel to a different product containing the same molecule.

If this contradicts something upthread, the upthread version may well be the better one.

17 likes 13mo

Suggested topics

Topic	Participants	Replies	Views	Activity
Why a compound being unapproved is not the same as being illegal to possess Sourcing › Regulatory FDA MHRA research use only EMA Why a compound being unapproved is not the same as being illegal to possess I have a specific reason for asking rather than idle curiosity, and the context is below. Collecting what is known about compound…	+72	78	23k	3mo
Import rules for personal quantities, by jurisdiction, dated Sourcing › Regulatory compounding MHRA FDA personal import On the subject in the title: Import rules for personal quantities, by jurisdiction, dated Working notes rather than a conclusion. I was wrong about import rules for personal quantities in a thread last spring…		3	60k	12mo
Pharmaceutical compounding rules, summarised from primary sources Sourcing › Regulatory MHRA EMA research use only Closed Pharmaceutical compounding rules, summarised from primary sources — setting out what I have, and where I think it stops being reliable. Asking what a regulator's document actually says, since the summaries of…	+135	163	46k	17mo
What a regulator's shortage notice actually authorises Sourcing › Regulatory personal import research use only EMA FDA Solved What a regulator's shortage notice actually authorises — that is the question, and I have not found it answered plainly anywhere I have looked. Asking what a regulator's document actually says, since the…	+8	12	15k	17h
Enforcement priorities versus written rules Sourcing › Regulatory FDA personal import MHRA Enforcement priorities versus written rules — setting out what I have, and where I think it stops being reliable. Asking what a regulator's document actually says, since the summaries of it disagree. I have…		2	62k	15mo

Related topics — sharing the tags research use only, MHRA, FDA

Topic	Participants	Replies	Views	Activity
Second pass at: Reimbursement variation across member states Regional › European Union personal import formulary cost per milligram EMA On the subject in the title: Second pass at: Reimbursement variation across member states Working notes rather than a conclusion. The question about Reimbursement variation across member states that I…	+23	28	45k	21mo
Canadian access and provincial variation Regional › North America compounding telehealth FDA insurance Posting this under the heading it deserves: Canadian access and provincial variation Everything below is what sits behind that. Trying to establish the boundary conditions on canadian access and provincial…	+74	80	7.7k	18mo
Coverage in the US: a map of the usual obstacles Regional › North America FDA insurance telehealth compounding Coverage in the US: a map of the usual obstacles — setting out what I have, and where I think it stops being reliable. Trying to establish the boundary conditions on coverage. The general claim is fine; I…	+46	50	7.9k	5mo
Personal import allowances, compared — a second dataset Access › International personal import telehealth MHRA EMA Wiki Personal import allowances, compared — a second dataset — setting out what I have, and where I think it stops being reliable. Posting a small dataset on Personal import allowances. It is mine, it is…	+124	132	9.2k	2mo
Pharmaceutical compounding rules, summarised from primary sources Sourcing › Regulatory MHRA EMA research use only Closed Pharmaceutical compounding rules, summarised from primary sources — setting out what I have, and where I think it stops being reliable. Asking what a regulator's document actually says, since the summaries of…	+135	163	46k	17mo