Research Catalog

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 : 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.
Publication
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]

Available Online

https://purl.fdlp.gov/GPO/LPS112495

Details

Additional Authors
Center for Biologics Evaluation and Research (U.S.)
Description
i, 13 pages : digital, PDF file
Alternative Title
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
Subject
  • Gene therapy > United States > Testing
  • Retroviruses > United States
  • Clinical trials > United States
Note
  • Title from PDF title page (viewed on May, 12, 2009).
  • "November 2006."
Bibliography (note)
  • Includes bibliographical references (pages 10-11).
System Details (note)
  • 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.
Call Number
GPO Internet HE 20.4802:R 31
OCLC
marcive320838766
Title
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.
Publisher
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]
Type of Content
text
Type of Medium
computer
Type of Carrier
online resource
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.
Bibliography
Includes bibliographical references (pages 10-11).
Connect to:
https://purl.fdlp.gov/GPO/LPS112495
Added Author
Center for Biologics Evaluation and Research (U.S.)
Gpo Item No.
0499-T-02 (online)
Sudoc No.
HE 20.4802:R 31
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