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2011-11-26
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Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
Notices
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D09002ee1bdcd0faa
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 for industry entitled ``Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.'' The purpose of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late-occurring irreversible radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. This guidance finalizes the draft guidance of the same name issued in June 2005.
76 FR 72952
https://www.govinfo.gov/app/details/FR-2011-11-28/2011-30474
2011-30474
fr28no11-73
4160-01-P
Docket No. FDA-2005-D-0086 (formerly Docket No. 2005D-0223)
https://www.govinfo.gov/app/details/FR-2011-11-28/2011-30474
https://www.govinfo.gov/content/pkg/FR-2011-11-28/html/2011-30474.htm
https://www.govinfo.gov/content/pkg/FR-2011-11-28/pdf/2011-30474.pdf
2 p.
72952
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76 FR 72952
Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability; Federal Register Vol. 76, Issue
NOTICE
2011-30474
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2005-D-0086 (formerly Docket No. 2005D-0223)
4160-01-P
2011-30474
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.'' The purpose of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late-occurring irreversible radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. This guidance finalizes the draft guidance of the same name issued in June 2005.
Submit either electronic or written comments on Agency guidances at any time.
Adebayo Laniyonu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2350, Silver Spring, MD 20993-0002, (301) 796-2050; or Siham Biade, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2311, Silver Spring, MD 20993-0002, (301) 796-2050.
Guidance for Industry; Availability:
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 76, no. 228
Office of the Federal Register, National Archives and Records Administration
2011-11-28
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2011-11-28
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https://www.govinfo.gov/content/pkg/FR-2011-11-28/pdf/FR-2011-11-28.pdf
https://www.govinfo.gov/content/pkg/FR-2011-11-28/xml/FR-2011-11-28.xml
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