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.
D002986:Clinical Trials as Topic / Q000379:methods*; D015316:Genetic Therapy / Q000379:methods*; D006801:Humans; D012190:Retroviridae / Q000235:genetics* / Q000378:metabolism; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration