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Male Breast Cancer: Developing Drugs for Treatment Draft Guidance for Industry August 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-2966
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Oncology Center of Excellence
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, 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

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?

Contact Point
Human Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
druginfo@fda.hhs.gov
(855) 543-3784 Toll Free
(301) 796-3400
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010