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GUIDANCE DOCUMENT

Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors Guidance for Industry November 2006

Final

Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors

Docket Number:
99D-4114
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document applies to the manufacture of gene therapy retroviral vector products intended for in vivo or ex vivo use and to follow-up monitoring of patients who have received retroviral vector products.1  Guidance is provided for replication competent retrovirus (RCR) testing during manufacture, including timing, amount of material to be tested, and general testing methods. In addition, guidance is provided on monitoring patients for evidence of retroviral infection. This guidance document finalizes the draft guidance document “Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors” announced in the Federal Register of November 3, 1999 (64 FR 59783). The guidance document also supplements the guidance and recommendations pertaining to RCR testing given in the following documents: 1) “Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy,” March 1998; and 2) a letter to Sponsors of INDs Using Retroviral Vectors, dated September 20, 1993. For general guidance on gene therapy refer to “Guidance for
Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy,” March 1998. 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 99D-4114.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010