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.

Bibliographic Details
Corporate Author:	Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]
Subjects:	Gene therapy > United States > Testing. Retroviruses > United States. Clinical trials > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS112495

Description
Item Description:	Title from PDF title page (viewed on May, 12, 2009). "November 2006." Electronic resource.
Physical Description:	i, 13 pages : digital, PDF file.
Format:	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).