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2020-08-12
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Male Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability
Notices
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D09002ee1c10242bf
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Male Breast Cancer: Developing Drugs for Treatment.'' This guidance provides recommendations regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. Specifically, this guidance recommends the inclusion of male patients in clinical trials of breast cancer drugs and provides recommendations on clinical development when males have either not been included in clinical trials for drugs to treat breast cancer or when inclusion of males in those trials is very limited. The development of drugs for male breast cancer may provide clinical data and additional FDA-approved treatment options to improve the clinical management of breast cancer in male patients. The guidance announced in this notice finalizes the draft guidance of the same title issued on August 27, 2019.
85 FR 48706
https://www.govinfo.gov/app/details/FR-2020-08-12/2020-17575
2020-17575
fr12au20-47
4164-01-P
Docket No. FDA-2019-D-2966
https://www.govinfo.gov/app/details/FR-2020-08-12/2020-17575
https://www.govinfo.gov/content/pkg/FR-2020-08-12/html/2020-17575.htm
https://www.govinfo.gov/content/pkg/FR-2020-08-12/pdf/2020-17575.pdf
3 p.
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85 FR 48706
Male Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-17575
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2019-D-2966
4164-01-P
2020-17575
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Male Breast Cancer: Developing Drugs for Treatment.'' This guidance provides recommendations regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. Specifically, this guidance recommends the inclusion of male patients in clinical trials of breast cancer drugs and provides recommendations on clinical development when males have either not been included in clinical trials for drugs to treat breast cancer or when inclusion of males in those trials is very limited. The development of drugs for male breast cancer may provide clinical data and additional FDA-approved treatment options to improve the clinical management of breast cancer in male patients. The guidance announced in this notice finalizes the draft guidance of the same title issued on August 27, 2019.
The announcement of the guidance is published in the Federal Register on August 12, 2020.
Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240- 402-0489; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Guidance:
Male Breast Cancer: Developing Drugs for Treatment,
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 156
Office of the Federal Register, National Archives and Records Administration
2020-08-12
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Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2020-08-12
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https://www.govinfo.gov/content/pkg/FR-2020-08-12/xml/FR-2020-08-12.xml
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FR-2020-08-12
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