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GUIDANCE DOCUMENT

Male Breast Cancer: Developing Drugs for Treatment Guidance for Industry August 2020

Final

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-N-1027


Docket Number:
FDA-2014-N-1027
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer.

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