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# Guide on Drugs for Treating Male Breast Cancer
- URL: https://www.fdaweb.com/guide-on-drugs-for-treating-male-breast-cancer/
- Published: 2019-08-27T12:00:00.000Z
- Updated: 2026-09-15T01:46:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144863

*Federal Register* notice: FDA has made available a draft guidance entitled “Male Breast Cancer: Developing Drugs for Treatment.” The document provides recommendations on the development and labeling of cancer drugs for treating male patients with breast cancer. It also 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-08-27/pdf/2019-18363.pdf?ref=fdaweb.com).