The Resource Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product

Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product

Label
Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
Title
Guidance for industry and FDA staff
Title remainder
submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
Title variation
Submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
Contributor
Subject
Language
eng
Cataloging source
GPO
Government publication
federal national government publication
Index
index present
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • United States
  • Center for Biologics Evaluation and Research (U.S.)
http://library.link/vocab/subjectName
  • Dispute resolution (Law)
  • Drug approval
  • Chemotherapy, Combination
Label
Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
Link
http://purl.access.gpo.gov/GPO/LPS114925
Instantiates
Publication
Note
  • Title from PDF title page (viewed on July 16, 2009)
  • "05/2004"--Online title index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Control code
17614514
Dimensions
unknown
Extent
7 pages
Form of item
electronic
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
digital, PDF file
Specific material designation
remote
System details
Mode of access: Internet at the FDA web site. Address as of 7/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147126.pdf ; current access is available via PURL
Label
Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
Link
http://purl.access.gpo.gov/GPO/LPS114925
Publication
Note
  • Title from PDF title page (viewed on July 16, 2009)
  • "05/2004"--Online title index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Control code
17614514
Dimensions
unknown
Extent
7 pages
Form of item
electronic
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
digital, PDF file
Specific material designation
remote
System details
Mode of access: Internet at the FDA web site. Address as of 7/16/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147126.pdf ; current access is available via PURL

Library Locations

    • Indiana State LibraryBorrow it
      315 W. Ohio St., Indianapolis, IN, 46202, US
      39.77004 -86.164015

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