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Enforcement priorities versus written rules

Sourcing › Regulatory FDA personal import MHRA

n.silvaTL21 Mar 2025#1

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 the primary document open and two secondhand accounts of it that cannot both be right. The primary document is narrower than either.

My question is whether I am reading the scope of it correctly, and what the correct reading rules out as well as what it permits.

0 likes 17mo

m.ivaturiTL28 Apr 2025#2

Thank you for taking the time. That was more work than a reply usually is.

26 likes 16mo

n.vogelTL25 May 2025#3

Preclinical versus clinical: compounds with strong preclinical data can fail in clinical trials. Compounds with no human data are being used on theoretical grounds. The regulatory position reflects this asymmetry.

12 likes 15mo

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