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

摘要

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. 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 This guidance document finalizes the draft guidance document 'Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of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.