Zdrowie i gospodarka · 18/10/2000

"Guidance for Industry: 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;" Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: 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" dated October 2000. The guidance document applies to the manufacture of gene therapy retroviral vector products intended for in vivo or ex vivo use and to followup monitoring of patients who have received retroviral vector products. The guidance document announced in this notice finalizes the draft guidance document entitled "Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy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. The guidance document also supplements the guidance document entitled "Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy," dated March 1998; and a letter to sponsors of an investigational new drug using retroviral vectors, dated September 20,