About us
FDA Drug Regulatory Intelligence is an independent, data-driven project, operated by Fidamen, that indexes public United States Food and Drug Administration (FDA) regulatory information — drug recalls (enforcement reports), drug shortages, and, where a dependable source is available, drug approvals. Our goal is to make these official records easier to find, read and verify, with every entry linking back to its authoritative FDA source.
What this project is
We are a reference and finding aid built on top of openFDA and official FDA datasets. For each record we reproduce the structured fields exactly as published by the agency, add a plain-language description of what the record is and how to interpret it in administrative terms, and link to the original source so you can confirm every detail yourself. The site is built as a static archive: it renders only the data that has been ingested and committed, so what you read is reproducible and traceable.
What this project is not
This site contains regulatory information only. It does not offer medical advice. It does not provide diagnosis, treatment, dosage, or therapeutic recommendations, and it never tells you whether to start, stop, switch, or avoid any product. A recall or shortage entry is an administrative fact about a regulatory action or a supply status — it is not a statement about the safety of any product for any individual. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.
Where the data comes from
Our recall data is drawn from the openFDA Drug Enforcement API, our shortage data from the FDA drug-shortages dataset, and any approvals layer from Drugs@FDA and the Orange Book. The full list of sources, their contents, their limits and their (non-guaranteed) update cadence is documented on our data sources page, and the way we ingest, normalise and publish the data is described on our methodology page.
Independence and affiliation
FDA Drug Regulatory Intelligence is an independent research project. It is not affiliated with, endorsed by, or operated by the U.S. Food and Drug Administration or any government agency. "FDA" and related names are used only to describe the public datasets we index. Any opinions, summaries or descriptions on this site are our own administrative characterisations of public records, not statements by the agency.
How the site is kept current
An automated pipeline re-ingests the upstream datasets on a schedule, recomputes a record-level change report, validates the result, rebuilds the site and publishes the refreshed data. You can see the latest dataset timestamps on the freshness page. If the upstream source check becomes stale, the pipeline fails on purpose rather than shipping data that silently fell behind.
Contact and corrections
If you believe a record is mislabelled, out of date, or does not match the official FDA source, the authoritative fix is always at the source itself — please report data issues to the FDA through the official channels linked on each record. For questions about this site, how it works, or this project in general, you can reach Fidamen by email at contact@fdadri.com. We treat the linked FDA source as the system of record and update our index from it rather than editing records by hand.