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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.

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All written comments should be identified with this document's docket number: FDA-2019-D-2966.

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