GUIDANCE DOCUMENT
Male Breast Cancer: Developing Drugs for Treatment Guidance for Industry August 2020
- Docket Number:
- FDA-2019-D-2966
- Issued by:
-
Guidance Issuing OfficeOncology Center of ExcellenceCenter for Drug Evaluation and ResearchCenter 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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