Coverart for item
The Resource Guidance for GDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)

Guidance for GDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)

Label
Guidance for GDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
Title
Guidance for GDA reviews and sponsors
Title remainder
content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
Title variation
Content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
Contributor
Subject
Language
eng
Cataloging source
GPO
Government publication
federal national government publication
Index
no index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
Guidance for GDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
Link
http://purl.access.gpo.gov/GPO/LPS111884
Instantiates
Publication
Note
  • Title from PDF title page (viewed on Apr. 24, 2009)
  • "April 2008"
Bibliography note
Includes bibliographical references (p. 32-34)
Carrier category
online resource
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type MARC source
rdacontent
Dimensions
unknown
Extent
online resource (ii, 34 p.)
Form of item
electronic
Media category
computer
Media MARC source
rdamedia
Other physical details
digital, PDF file.
Specific material designation
remote
System control number
  • (OCoLC)ocn319178291
  • (OCoLC)ocn506322766
System details
Mode of access: Internet at the GPO Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/gtindcmc.pdf ; current access is available viaPURL
Label
Guidance for GDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
Link
http://purl.access.gpo.gov/GPO/LPS111884
Publication
Note
  • Title from PDF title page (viewed on Apr. 24, 2009)
  • "April 2008"
Bibliography note
Includes bibliographical references (p. 32-34)
Carrier category
online resource
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type MARC source
rdacontent
Dimensions
unknown
Extent
online resource (ii, 34 p.)
Form of item
electronic
Media category
computer
Media MARC source
rdamedia
Other physical details
digital, PDF file.
Specific material designation
remote
System control number
  • (OCoLC)ocn319178291
  • (OCoLC)ocn506322766
System details
Mode of access: Internet at the GPO Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/gtindcmc.pdf ; current access is available viaPURL

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