Contents

Database Description

DIOGENES FDA Regulatory Updates provides access to the Food and Drug Administration (FDA) regulatory information and is the database of choice for those researching the market status of FDA-approved pharmaceutials and medical devices. The database includes:

• Premarket Notifications [510(k)s]. Every device ever declared substantially equivalent and therefore allowed onto the market under the Premarket Notification provisions of the Medical Device Amendments of 1976, including device name and classification, regulating advisory committee, sponsoring company, date of FDA decision, and 510(k) number.
• Premarket Approvals (PMAs). 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). Includes a record describing each adverse device experience submitted to the FDA from the beginning of the Medical Device Reporting plan in 1985.
• New Drug List (NDL). 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, Abbreviated New Drug Approval (ANDA) number, and data 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. It describes pharmaceuticals, medical devices, biologics, foods, radiological products, veterinary medical products, and cosmetics.

  All material is acquired directly from the FDA and describes the approval and regulation of these products.

  
  

  
  

  Subject Coverage

  
  

  
  

  Dialog File Data

  Dates Covered:	510(k)s and PMAs from 1976, MDRs from 1985, NDL from 1938, Reports from 1984
  File Size:	More than 1,532,000 records as of January 2006
  Update Frequency:	Weekly

  
  

  Contact

  Diogenes is produced by the FOI Services, Inc. Questions concerning file content should be directed to: FOI Services, Inc. 704 Quince Orchard Road Suite 275 Gaithersburg, MD 20878 Telephone: +1 301-975-9400 Fax: +1 301-975-0702 E-Mail: diogenes@foiservices.com

  
  

  Terms and Conditions

  DIOGENES is a registered trademark of FOI, Inc.
  

  All bibliographic information and record identification in DIOGENES FDA Regulatory Updates is fully protected by copyright. Reproduction or photocopying even for internal use without the publisher's permission is prohibited. While every effort has been made to ensure that the information in the database is correct, DIOGENES FDA Regulatory Updates cannot accept any responsibility for errors or omissions.

  
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