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Title Guidance for industry [electronic resource] : 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.

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

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:R 31    ---  Available
Description i, 13 p. : digital, PDF file
System Details Mode of access via the FDA CBER web site.
Note Title from PDF title page (viewed on May, 12, 2009).
"November 2006."
Bibliography Includes bibliographical references (p. 10-11).
Subject Gene therapy -- United States -- Testing.
Retroviruses -- United States.
Clinical trials -- United States.
Added Author Center for Biologics Evaluation and Research (U.S.)
Added 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
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:R 31

 
    
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