Reading a regulatory notice rather than an article about it — what changed since

Reading a regulatory notice rather than an article about it — what changed since — 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.

Agreed, and I will stop repeating the version of this I had been repeating.

Taking post #11 at face value and following it one step further.

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.

That is what the documentation says. What happens in practice is usually close.

Adding a reference point for Reading a regulatory notice. Mine is a single case, collected without controls, and I am posting the method alongside it so it can be discounted appropriately.

Worth separating two things that post #23 runs together.

Practical answer on Reading a regulatory notice, since the theoretical one is upthread: do the simplest check first, write down the result, and only then decide whether the complicated explanation is needed. It usually is not.