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182
FDAnews

Last Loaded on Web: Wednesday, May 01, 2013

Last Update To Bluesheet: May 12, 2005

Bluesheet Contents     PDF version

File Description Dialog File Data DIALINDEX/OneSearch Categories Basic Index Rank
Sources Document Types Indexed Contact Additional Indexes Predefined Format Options
Tips Geographic Coverage Terms and Conditions Limit Rates
Print Counterparts Special Features Sample Record Sort


File Description [top]

FDAnews provides domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration and The European Commission.

The database provides pharmaceutical and medical device professionals print and electronic newsletters, books, special reports, documents, and conferences that will help them stay in compliance with international standards and FDA's complex and ever-changing regulations to get their products to market faster and boost profits.



Tips [top]

USE FILE 182

to track regulatory and legislative information about the U.S. FDA and The European Commission.

USE /TI

to search for article titles.

USE THE PY=

prefix to restrict retrieval to records from certain years.

     SELECT PY=2004

EXPAND JN=

to see the latest list of publications in the database.



Subject Coverage [top]



Sources [top]

FDAnews is particularly strong in its coverage of clinical trials and generic drugs.

Some of the titles covered in the database include:

  • FDAnews Biodefense Alert
  • Clinical Trials Advisor
  • Daily International Pharma Alert
  • Devices & Diagnostics Letter
  • Drug GMP Report Monthly
  • Drug Industry Daily
  • FDAnews Device Daily Bulletin
  • FDAnews Drug Daily Bulletin
  • FDAnews Drug Pipeline Alert
  • FDAnews Nutraceutical Weekly Bulletin
  • The Food & Drug Letter
  • Generic Line
  • The GMP Letter
  • Part 11 Compliance Report
  • Washington Drug Letter


Print Counterparts [top]


Dialog File Data [top]

Dates Covered: 2000 to the present
File Size: Over 25,000 records as of March 2005
Update Frequency: Daily


Document Types Indexed [top]

  • Reports
  • Conferences, Symposia, Meetings
  • Newsletters
  • Books
  • Newswires


Geographic Coverage [top]

  • International


Geographic Restrictions [top]

  • None


Special Features [top]

  • ERA Available
  • KWIC and HILIGHT Available
  • DIALOG Alert Available
  • CURRENT Feature Available


DialIndex/OneSearch Categories [top]

ACRONYM CATEGORY NAME
BIOBUS Biosciences and Biotechnology Industry
DRUGECON Pharmacoeconomics
MEDDEV Medical Devices
MEDENG Medical Engineering
PHARMIND Pharmaceutical Industry News
PHARMR Pharmacology + RINGDOC-Files
PHARMREG Pharmaceutical Regulation
REGS Regulations


Contact [top]

FDAnews is produced by FDAnews. Questions concerning file content should be directed to:

FDAnews
Jodi Oberle
300 N. Washington St., Suite 200
Falls Church, VA 22046-3431

Telephone: 703-538-7600
800 Line: 888-838-5578
Fax: 703-538-7676
E-Mail: joberle@fdanews.com


Terms and Conditions [top]

FDAnews is copyrighted by Washington Business Information Inc.


Dialog Standard Terms & Conditions apply.


SAMPLE RECORD [top]

    DIALOG(R)File 182:FDAnews 
    (c) 2005 Washington Business Info. All rts. reserv. 
     
  AA=  0000002241  IE44B4BA06E2711D9BA549F056E469BC9  (THIS IS THE FULLTEXT) 
  /TI  COURT REJECTS MYLAN'S CHALLENGE TO DURAGESIC 
  JN=  Generic Line, v22, n1 
  DY=,PD=,PY=  Tuesday, January 11, 2005 
  JC=,LA=,RT=  JOURNAL CODE:  GELI  LANGUAGE:  ENGLISH  RECORD TYPE:  FULLTEXT 
  DT=  DOCUMENT TYPE:  Newswire 
    WORD COUNT: 448 
     
    TEXT: 
  /LP,/TX  Generic drugmaker Mylan Laboratories last month lost another round in its 
    legal battle to market a generic version of Johnson & Johnson's (J&J's) 
    Duragesic transdermal pain patch before J&J's pediatric exclusivity period 
    ends later this month and the patent on the product expires. 
     
    The U.S. Court of Appeals for the Federal Circuit rejected Mylan's 
    challenge to the validity of the patent on Duragesic (fentanyl) held by 
    Alza, a subsidiary of J&J in December 2004, effectively blocking Mylan from 
    entering the market with a generic version of the product before Alza's 
    pediatric exclusivity period ends. 
     
  /TX  "Because the district court correctly construed the claim term 'skin 
    permeable form' to exclude fentanyl citrate, we affirm its validity 
    determinations," the court said. "Further, because we discern no error in 
    the district court's, finding of a lack of intent to deceive, we affirm the 
    district court's holding that the '580 patent is not unenforceable due to 
    inequitable conduct." 
     
    Other Hurdles Facing Mylan 
     
    Earlier in December 2004, the U.S. Court of Appeals for the District of 
    Columbia upheld a ruling by a lower court that affirmed an FDA decision to 
    grant pediatric exclusivity to Alza. The pediatric exclusivity delays the 
    date of entry for Mylan's generic product to January 2005. 
     
    Mylan said it expected to launch its generic product no later than July 23, 
    2004, when the drug's patent was initially set to expire. Mylan had 
    received final FDA approval for its generic product, and the company 
    believed that neither a 30-month stay nor a pediatric exclusivity period 
    would apply. 
     
    Mylan asserted that because Alza didn't sue for patent infringement within 
    45 days of receiving Mylan's abbreviated new drug application (ANDA) with a 
    Paragraph IV certification, Alza is not allowed two exclusivity extensions 
    under the Hatch-Waxman Act. 
     
    Mylan sued the FDA when it granted six months of pediatric exclusivity to 
    Alza and converted approval status for Mylan's ANDA from final to tentative 
    for Duragesic (Generic Line, June 30, 2004, Page 1). Mylan then sought an 
    emergency court order to block this decision (Generic Line, July 28, 2004, 
    Page 2). But in August, the U.S. District Court for the District of 
    Columbia ruled against Mylan saying that the FDA had not acted improperly 
    when it withdrew the firm's ANDA for the Duragesic patch (Generic Line, 
    Aug. 25, 2004, Page 1). 
     
    Mylan is incurring substantial revenue losses as it pushes to market 
    generic Duragesic. The company spent hundreds of thousands of dollars on 
    perishable adhesive for the transdermal patches that will expire this 
    month. Mylan also spent money to hire security to support the production of 
    the patches and employees to produce them, as well as $14 million for 
    facilities, manufacturing, and lab equipment. 
     
         Copyright (c) 2005 Washington Business Information, Inc. 
     
  /CO,CO=  COMPANY NAMES:  JOHNSON AND JOHNSON 
  /DE  DESCRIPTORS:  exclusivity; pediatric; courts 
    DIALOG UPDATE DATE:  20050202; 13:36:32 EST 
  /DE,EN=  EVENT NAMES:  LEGAL 
  GN=  GEOGRAPHIC NAMES:  DISTRICT OF COLUMBIA; USA; AMERICAS; NORTH AMERICA 
  /PN,PN=  INDUSTRY NAMES:  PHARMACEUTICAL INDUSTRY 
  NO=  SUPPLIER NUMBER:  3057.34309.a 
     


BASIC INDEX [top]

SEARCH
SUFFIX		 DISPLAY
CODE		 FIELD NAME
 INDEXING
 SELECT EXAMPLES
None None All Basic Index Fields Word S PAIN(W)PATCH
/CO CO Company Name1 Word S JOHNSON(1W)JOHNSON/CO
/DE DE Descriptor2,3 Word
& Phrase		 S EXCLUSIVITY/DE
S PEDIATRIC/DE
/GN GN Geographic Name1 Word S USA/GN
/LP LP Lead Paragraph Word S MYLAN(W)LAB?/LP
/PN PN Industry/Product Name1 Word S PHARMACEUTICAL/PN
/TI TI Title Word S MYLAN(1W)CHALLENGE/TI
/TX TX Text Word S PATENT(S)DURAGESIC/TX

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

2 Also /DF.

3 Includes Event Names.


ADDITIONAL INDEXES [top]

SEARCH
PREFIX		 DISPLAY
CODE		 FIELD NAME
 INDEXING
 SELECT EXAMPLES
AA= AA Supplier Accession Number Phrase S AA=IE44B4BA06E2711?
None AZ DIALOG Accession Number
CO= CO Company Name1 Phrase S CO="JOHNSON AND JOHNSON"
DT= DT Document Type Phrase S DT=NEWSWIRE
DY= DY Publication Day Phrase S DY=TUESDAY
EN= EN Event Name1 Phrase S EN=LEGAL
GN= GN Geographic Name1 Phrase S GN=DISTRICT OF COLUMBIA
JC= JC Journal Code Phrase S JC=GELI
JN= JN Journal Name Phrase S JN=GENERIC LINE?
LA= LA Language Phrase S LA=ENGLISH
MO= MO Month Phrase S MO=JANUARY
NO= NO Source Number Phrase S NO=3057.343?
PD= PD Publication Date Phrase S PD=20050111
PN= PN Industry/Product Name1 Phrase S PN=PHARMACEUTICAL?
PY= PY Publication Year Phrase S PY=2005
RT= RT Record Type Phrase S RT=FULLTEXT
None SO Source Information
UD= None Update Phrase S UD=9999
None WD Word Count


LIMIT [top]

SUFFIX FIELD NAME EXAMPLES
/ENG English Language Record S S2/ENG
/FULLTEXT Fulltext Record S S3/FULLTEXT
/LONG Record is > 1,000 Words S S2/LONG
/NONE Publication Year S S2/2003
/NONENG Non-English Language Record S S2/NONENG
/SHORT Record is < 1,000 Words S S2/SHORT


SORT [top]

SORTABLE FIELDS EXAMPLES
AA, JN, PD, PY, TI SORT S6/ALL/JN
PRINT S3/5/1-24/PD,D


RANK [top]

RANK FIELDS EXAMPLES
All phrase- and numeric-indexed fields in the Additional Indexes can be ranked. RANK JN


USER-DEFINED FORMAT OPTIONS [top]

Display codes listed in the Search Options tables can be used to customize output. TYPE S3/TI,PD/1-5


PREDEFINED FORMAT OPTIONS [top]

NO.
 DIALOGWEB
FORMAT		 RECORD CONTENT
1 -- DIALOG Accession Number
2 -- Full Record except Text
3 Medium Bibliographic Citation
4 -- Bibliographic Citation, Lead Paragraph, and Word Count
5 Long Bibliographic Citation, Indexing, Lead Paragraph, and Word Count
6 Free Title, Publication Date, and Word Count
7 -- Full Record except Indexing
8 Short Title, Publication Date, Word Count, and Indexing
9 Full Full Record
K -- KWIC (Key Word In Context) displays a window of text; may be used alone or with other formats


DIRECT RECORD ACCESS [top]

FIELD NAME EXAMPLES
If the accession number of a specific record is known, it can be used to display the record directly. TYPE 00004724/5
DISPLAY 00004704/CO,PN
PRINT 00004392/2


Rates [top]

Rates For File: FDAnews[182]
Cost per DialUnit:                $18.61
Cost per minute:                   $4.20
ALERT (default)                   $10.50
ALERT (Monthly)                   $71.00
ALERT (Biweekly/twice a month)    $50.00
ALERT (Weekly)                    $36.00
ALERT (Daily)                     $10.50
ALERT (Calendar weekly)        *  $36.00
ALERT (Intraday)                  $10.50
* = custom scheduled Alerts only
ALERT Number of included prints        0

Format    Types   Prints
     1    $0.00    $0.00
     2    $4.00    $4.00
     3    $4.00    $4.00
     4    $8.00    $8.00
     5   $11.00   $11.00
     6    $0.00    $0.00
     7    $8.00    $8.00
     8    $0.00    $0.00
     9   $11.00   $11.00
KWIC95    $4.00       NA
KWIC96    $4.00       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
[top]


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