Support : Publications : Chronolog Archives : September 2001

DIOGENES^® FDA Regulatory Updates Reloaded on DataStar™

DIOGENES FDA Regulatory Updates has been reloaded on DataStar. DIOGENES (DataStar file DIOG) is the most comprehensive source of information relating to the regulation of human drugs and medical devices by the US Food and Drug Administration (FDA). The database contains unpublished FDA documents acquired under the Freedom of Information Act which include Advisory Committee Minutes, Drug and Device Approval information, Regulatory Letters, Establishment Inspection Reports, and others. In addition the fulltext of several newsletters providing summaries of topical issues which affect health care and FDA-regulated industry are included.

DIOGENES has been reloaded and enhanced to include five new paragraphs:

1. PC — Product Category: includes the following terms: Drug, Device, Biologic, Veterinary, Food. Search: DRUG.PC.
   
   
2. AD — Address: The address of the Company named in the CO -- Company name paragraph. Search: MIAMI.AD.
   
   
3. DE — Descriptors: Device classification, FDA Device code, Dosage form, Route of Administration and Keywords. Search: ROUTE WITH INTRAVENOUS. DE. or DOSAGE WITH CAPSULE.DE.
   
   
4. ST — Status: The date a drug or device application was submitted, the type of submission for a device, the type of supplement for a device approval, FDA assigned code, the reason and date a drug has had approval withdrawn, the date a drug will no longer have marketing exclusivity and the substantial equivalence text. Search: LABELLING ADJ CHANGE.ST. or 510K.ST.
   
   
5. Notes (NT) — notes regarding a special situation with a document.

There is no change to the pricing.

Please refer to the online Datasheet at: http://library.dialog.com/datasheets or the complete database guide in BASE. Search BASE-DIOG.

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