DIOGENES ® - FDA Regulatory Information OnlineNote: this file will be available on Dialog through the end of 2012, but it is no longer supported. Last update date 12/31/2011.
The online database DIOGENES is the file of choice for those researching the market status of U.S.. Food and Drug Administration-approved pharmaceuticals and medical devices. Redesigned in July, 2005, the file now includes the following data types:
- Premarket Notifications [510(k)s]. -- DIOGENES lists every device ever declared substantially equivalent, and therefore allowed onto the market under the Premarket Notification provisions of the Medical Device Amendments of 1976. Information available includes device name and classification, regulating advisory committee, sponsoring company, date of FDA decision, and 510(k) number.
- Premarket Approvals (PMAs) -- Supplementing the listing of 510(k)s is the listing of all medical devices approved under the Premarket Approval provisions of the Medical Device Amendments of 1976. Individual entries include device name and manufacturer, date of approval, and regulating advisory committee.
- Medical Device Reports (MDRs) -- Covering back to the beginning of the Medical Device Reporting plan in 1985, this data set includes a record describing each adverse device experience submitted to the FDA.
- New Drug List (NDL) -- The DIOGENES database includes a listing of every drug ever allowed onto the U.S. market since approval requirements began in 1938. Individual records include drug generic and trade names, manufacturer, dosage strength and form, New Drug Approval (NDA) or Abbreviated New Drug Approval (ANDA) number, and date of approval. For affected drugs, date of market withdrawal, date of withdrawal of FDA permission to market, Waxman-Hatch patent number, patent expiry, and patent exclusivity dates are also included.
- The Enforcement Report -- Covering back to 1984, each record of The Enforcement Report describes an instance of FDA-recorded field corrections and product recalls, indexed by company, product, recall number, extent of recall and recall narrative. The Enforcement Report describes pharmaceuticals, medical devices, biologics, foods, radiological products, veterinary medical products, and cosmetics.
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