The Resource Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors

Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors

Label
Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
Title
Guidance for industry
Title remainder
supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
Title variation
Supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
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
http://library.link/vocab/relatedWorkOrContributorName
Center for Biologics Evaluation and Research (U.S.)
http://library.link/vocab/subjectName
  • Gene therapy
  • Retroviruses
  • Clinical trials
Label
Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
Link
http://purl.access.gpo.gov/GPO/LPS112495
Instantiates
Publication
Note
  • Title from PDF title page (viewed on May, 12, 2009)
  • "November 2006."
Bibliography note
Includes bibliographical references (pages 10-11)
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
17609522
Dimensions
unknown
Extent
i, 13 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 CBER web site. Address as of 5/12/09: http://www.fda.gov/cber/gdlns/retrogt1000.pdf ; current access is available via PURL
Label
Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
Link
http://purl.access.gpo.gov/GPO/LPS112495
Publication
Note
  • Title from PDF title page (viewed on May, 12, 2009)
  • "November 2006."
Bibliography note
Includes bibliographical references (pages 10-11)
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
17609522
Dimensions
unknown
Extent
i, 13 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 CBER web site. Address as of 5/12/09: http://www.fda.gov/cber/gdlns/retrogt1000.pdf ; current access is available via PURL

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