GUIDANCE DOCUMENT
Male Breast Cancer: Developing Drugs for Treatment Guidance for Industry August 2019
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2019-D-2966
- Docket Number:
- FDA-2019-D-2966
- Issued by:
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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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