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

Issue Date: August 12, 2020
Issued by: Oncology Center of Excellence
Topic(s): Clinical – Medical
Status: Final

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

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.

Download the Guidance Document

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