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2010-09-24
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``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
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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 The guidance document announced in this notice finalizes the draft guidance document entitled ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy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, 1993.
65 FR 62364
https://www.govinfo.gov/app/details/FR-2000-10-18/00-26670
00-26670
fr18oc00-68
4160-01-F
Docket No. 99D-4114
https://www.govinfo.gov/app/details/FR-2000-10-18/00-26670
https://www.govinfo.gov/content/pkg/FR-2000-10-18/html/00-26670.htm
https://www.govinfo.gov/content/pkg/FR-2000-10-18/pdf/00-26670.pdf
2 p.
62364
62365
65 FR 62364
``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; Federal Register Vol. 65, Issue
NOTICE
00-26670
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 99D-4114
4160-01-F
00-26670
Notice.
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, 1993.
Submit written comments at any time.
Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827- 6210.
Reports and guidance documents; availability, etc.:
Testing for replication competent retrovirus in retroviral vector based gene therapy products, etc.; supplemental guidance,
http://www.fda.gov/cber/guidelines.htm
Federal Register
Vol. 65, no. 202
Office of the Federal Register, National Archives and Records Administration
2000-10-18
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311 p.
Table of Contents:
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https://www.govinfo.gov/content/pkg/FR-2000-10-18/xml/FR-2000-10-18.xml
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2010-09-24
2023-05-05
FR-2000-10-18
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FR-2000-10-18
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