How the record is built.

Each decision is one case. A case is built by running the kgx pipeline over the decision's FDA documents: every page is read, split into sentences with their page numbers, and turned into a knowledge graph. No language model is used anywhere in it.

An editor picks the sentences that state the agency's position on each thread. The exporter then finds each sentence again on the PDF page it came from and copies it from there. If the words are not on that page, the build stops. Dates, committee votes, the basis of approval and the confirmatory terms are read from the documents the same way, never typed in.

Each position is compared to a named earlier position on the same thread and marked with one status. The first position on a thread is its origin.

Origin

The first agency position on this thread in the record.

Consistent

Holds to the earlier position it is compared to.

Conditional

Holds to the earlier position only under a condition the agency states.

Departs

Moves away from the earlier position it is compared to.

Not addressed

The decision's loaded documents do not address this thread.

Scope: the list of every FDA-approved Alzheimer's drug is read from openFDA's drug labels (any current label whose indication names Alzheimer's disease, plus discontinued brands of the same ingredients) and the Drugs@FDA database, refreshed weekly; its indication quotes are checked against the label text word for word. The in-depth record covers anti-amyloid antibody decisions. A decision whose documents are not loaded yet shows as record incomplete, with what is missing.

Citations give the PDF page number, which can differ from the page number printed on the document.

What this record cannot show

The record is only as complete as what FDA publishes. Where FDA is silent, the page says so rather than filling the gap.

• Applications under review. FDA does not disclose them. A pending application becomes visible only through FDA's own notices, such as an advisory committee meeting announced in the Federal Register, or once FDA acts. The index shows what was checked and when.
• Events FDA has not recorded. A product can leave the market without an FDA document saying so. The record shows what FDA's database and notices say, with the date they were checked, and does not substitute other accounts.
• Reviews FDA has not posted. FDA posts reviews for some supplements late or not at all. Those entries are built from the approval letter and label, and the source list says which documents exist.
• Documents FDA has taken down. Some advisory committee files are no longer served by fda.gov. Where the Internet Archive holds the original file, the citation keeps FDA's address and links the archived copy, labelled as such.
• Scanned pages. Where a page is an image, a quote is used only if FDA's own transcription and an independent reading of the page agree line by line.