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File Description [top]

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.

  
  

  
  

  Tips [top]

  USE FILE 158 to monitor regulatory milestones for the pharmaceutical and medical device industry. EXPAND ON AC=, DT=, AND SO= to choose Advisory Committee, Device, or Source:      E AC=ADVISORY COMMITTEE      E DT=DEVICE      E SO=510K ENTER SELECT STATEMENT AND RANK CO to see which companies are working in an area of interest:      S (SO=510K AND (IMMUNO(W)ASSAY? OR IMMUNOASSAY?))/1996      RANK CO

  
  

  Subject Coverage [top]

  
  

  
  

  Sources [top]

  DIOGENES FDA Regulatory Updates is made up of unpublished U.S. FDA documents acquired under the Freedom of Information Act, including: Advisory Committee minutes, drug and device approval information, regulatory letters, Establishment Inspection reports, Industry/FDA correspondence, and recall documentation.

  
  

  
  

  Print Counterparts [top]

  • None

Dialog File Data [top]

Document Types Indexed [top]

• Government Documents
• Press Releases

Geographic Coverage [top]

• US Only

Geographic Restrictions [top]

• None

Special Features [top]

• ERA Available
• Graduate Education Program
• KWIC and HILIGHT Available
• DIALOG Alert Available
• Remove Duplicates (RD, ID) Available

DialIndex/OneSearch Categories [top]

Contact [top]

Terms and Conditions [top]

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.

SAMPLE RECORD [top]

BASIC INDEX [top]

¹ Searchable in the Basic Index and in the Additional Indexes.

² Also /IF.

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Rates [top]

Rates For File: DIOGENES® FDA Regulatory Updates[158]
Cost per DialUnit:                $10.53
Cost per minute:                   $2.52
Rank Elements                      $0.00

Format    Types   Prints
     1    $0.00    $0.00
     2    $3.50    $3.50
     3    $3.50    $3.50
     4    $9.00    $9.00
     5    $9.00    $9.00
     6    $0.00    $0.00
     7    $9.00    $9.00
     8    $0.00    $0.00
     9    $9.00    $9.00
KWIC95    $1.50       NA
KWIC96    $1.50       NA

REDIST/COPY Multiplier Table:

      Range      Multiplier
        1-2       1.00
       3-25       1.50
     26-100       3.00
    101-200       4.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

ARCHIVE Multiplier Table:

      Range      Multiplier
       1-25       1.50
     26-200       3.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00