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]
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
