Docket Number:
FDA-1999-D-0081
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The potential pathogenicity of replication competent retrovirus (RCR) requires vigilant testing to exclude the presence of RCR in vector-based human gene therapy products (Ref. 1). We, the FDA, are providing you, sponsors of retroviral vector-based human gene therapy products,recommendations regarding the testing for RCR during the manufacture of retroviral vector based gene therapy products, and during follow-up monitoring of patients who have received retroviral vector-based gene therapy products. Recommendations include the identification and amount of material to be tested as well as general testing methods. In addition, recommendations are provided for monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products.

Submit Comments

Submit Comments Online

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1999-D-0081.

Questions?