Reading the record
How quotes, citations, page numbers, scanned pages and placeholders work across every EphemerisX site.
Every EphemerisX site follows the same rules for showing what a public document says. Once you know them, you can read any page and check any claim yourself.
Quotes are verbatim#
Text shown as a quote is copied word for word from an FDA or SEC document. EphemerisX does not paraphrase, summarise or write sentences in the agency's voice. Where a site needs its own words (headings, labels, notes), they are visibly separate from the quotes.
On the FDA drug record, the footer states it plainly: “Every sentence on this site is quoted from an FDA document and links to its page on fda.gov.”
Citations#
Every quote is followed by a citation. Citations share one format:
<Document title> · PDF p. <N> · action of <date> · fda.gov ↗For example: Summary Review · PDF p. 5 · fda.gov ↗. Select the citation to open the source document on fda.gov.
PDF page numbers#
To jump to the cited page, use your PDF viewer's page box, or add #page=N to the end of the fda.gov address in most browsers.
Scanned pages#
Some older FDA documents are stored as images of paper pages. Their text was read by optical character recognition (OCR). A citation from such a page is marked:
- Alzheimer's record: “· scanned page, OCR-checked”. Hover the citation to see the transcription.
- FDA drug record: “· read by OCR”.
When you check a quote from a scanned page, expect small differences in spacing or punctuation.
Documents the FDA has taken down#
The FDA sometimes moves or removes a document. When that happens, the source link says so. For example, “No longer on fda.gov · archived copy”. It links to an independent copy in the Internet Archive instead.
Placeholders#
When a part of the record has not been loaded yet, the page does not guess. It shows a bracketed placeholder in a dashed box, for example [basis not loaded] or [no position recorded on this thread]. A decision whose documents are not all loaded is tagged Record incomplete and lists what is missing.
Dates#
- Action date: the date on the FDA's letter (approval or complete response).
- First approved: the first approval of the application. It can be earlier than the indication you are reading about.
- Checked or Last checked: when the page was last compared with the agency's current documents.
What the sites do not do#
- They do not assess whether a drug works or is safe.
- They do not list applications the FDA has not made public. See Pending applications.
- They do not show events the FDA has not recorded, or reviews it has not posted.