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GUIDANCE DOCUMENT

Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials November 2018

Draft

Not for implementation. Contains non-binding recommendations.

Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials

Docket Number:
FDA-2018-D-3931
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.” This draft guidance provides recommendations to sponsors regarding the use of metastasis-free survival (MFS) as an endpoint in clinical trials for nonmetastatic, castration-resistant prostate cancer (nmCRPC) development programs for drug or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).


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All written comments should be identified with this document's docket number: FDA-2018-D-3931.