REGAFFAIRS AI
ARTICLES

Notes on doing the research.

Industry-neutral writing about the work itself: how to cite a paragraph, when to stop, and what a trail is for. Not product announcements.

GUIDE · 2026-10-02 · 3 min
Humira package insert and where to find the current FDA label

The current Humira package insert is FDA supplement S-425, Revised 12/2025, on Drugs@FDA (BLA 125057) and DailyMed. Where to get it and what it contains.

GUIDE · 2026-10-02 · 5 min
Natasha's Law explained, allergen labels for UK PPDS food

Natasha's Law requires UK food prepacked for direct sale to carry its name and a full ingredients list with the 14 allergens emphasised, from 1 Oct 2021.

GUIDE · 2026-10-01 · 6 min
Controlled substance schedules I to V and the official DEA list

A controlled substance schedule is one of five US categories (I to V) set by the Controlled Substances Act. The binding list is 21 CFR Part 1308.

GUIDE · 2026-10-01 · 8 min
Environmental clearance in India, who needs EC and how to apply

Environmental clearance (EC) is prior approval under the EIA Notification 2006 for listed projects. See Category A vs B, the process, documents and SEIAA.

GUIDE · 2026-09-30 · 7 min
How to use the CosIng database to check a cosmetic ingredient

CosIng is the European Commission's free database of cosmetic ingredients, INCI names and Annex entries. How to search it and what it can't tell you.

METHOD · 2026-09-08 · 7 min
Evaluating an answer you did not write

A short checklist for reading a cited regulatory answer under time pressure, whether it came from a colleague, a consultant or a research agent.

WORK · 2026-09-07 · 7 min
The first pass, before the consultant

Retainers are for judgement. Status checks, scope questions and cross-market deltas should not wait for a kickoff call. How to split the work.

METHOD · 2026-09-05 · 9 min
How to read an annex without getting lost

Most of the binding detail in a modern instrument lives in a table. A short method for not missing the row that actually applies.

TRUST · 2026-09-02 · 8 min
When the record is silent

The most expensive regulatory answers are the ones that fill a gap with a plausible sentence. How to treat silence as a finding.

RESEARCH · 2026-08-26 · 10 min
The same duty, several markets

Cross-market regulatory questions fail when they are answered as eight separate memos. How to ask for the differences that actually change the work.

METHOD · 2026-08-19 · 8 min
What a research trail is for

An answer without a method is a claim. Why the steps behind a regulatory answer belong on the same page as the sentence you will quote.

METHOD · 2026-08-12 · 9 min
Cite the paragraph, not the document title

A regulatory answer you cannot re-find is not an answer. How to pin a claim to the instrument, annex and paragraph someone else can open.