FDA drug record overview
The FDA drug record at ephemerisx.com/drugs/ publishes one page per drug, quoted from the FDA's own review documents and label.
The FDA drug record, at ephemerisx.com/drugs, is a library of drug pages. Each page answers the same questions for one drug, using only the FDA's documents: what it is approved for, which trials the FDA reviewed, the results it reported, safety, dosing, and which documents were read.
How the library is organised#
| Level | Address | Shows |
|---|---|---|
| Home | /drugs | What the FDA record says, drug by drug. One card per disease area, with its number of drugs. |
| Disease area | /drugs/<disease> | A table of the area's drugs: Drug, Sponsor, First approved and FDA documents, newest approval first. |
| Drug | /drugs/<drug> | The drug's page. See Read a drug page. |
| Method | /drugs/method | How the pages are made, how they are checked, and what is not on them. |
Disease areas#
The library grows by disease area. An area appears on the home page once it has at least one published drug:
- Alzheimer's disease, /drugs/alzheimers
- Obesity and weight management, /drugs/obesity
- Cancer, /drugs/oncology
At the foot of a disease page, “Being checked before publication” lists drugs that are built but not yet published.
Navigation#
- The site name, FDA drug record, returns to /drugs.
- The breadcrumb shows / Disease / Drug; select the disease to go back to its table.
- Method is the only other link in the header.
The site has no search box. Use your browser's find (Ctrl+F or ⌘+F) on a disease page to find a drug.
How current the pages are#
Every page is re-checked against the FDA's copies of its documents weekly. When the FDA changes or removes a document, the page says so. The date of the last check is at the foot of each drug page's document table.
Drug status#
The Status fact on a drug page is one of:
| Status | Meaning |
|---|---|
| Approved | The FDA approved the application. |
| Accelerated approval | Approved under the accelerated approval pathway, pending confirmatory evidence. |
| Accelerated approval, converted to traditional approval | Later granted traditional approval. |
| Not approved (complete response letter) | The FDA issued a complete response letter. |
| Withdrawn | The approval was withdrawn. |
| Discontinued | No longer marketed. |
| Under review | The application is before the FDA and has no action yet. |