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GUIDANCE DOCUMENT

Male Breast Cancer: Developing Drugs for Treatment Draft Guidance for Industry August 2019

Download the Draft Guidance Document
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Not for implementation.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.

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

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