U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Male Breast Cancer: Developing Drugs for Treatment
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-2966
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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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-2019-D-2966.

Questions?

Back to Top