Nonmetastatic castration-resistant prostate cancer: considerations for metastasis-free survival endpoint in clinical trials

Collection:: Health Policy and Services Research
Series Title(s):: Guidance for industry
Contributor(s):: United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2021
Language(s):: English
Format:: Text
Subject(s):: Clinical Trials as Topic
Prostatic Neoplasms, Castration-Resistant
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):: Technical Report
Abstract:: This guidance provides recommendations to sponsors about using 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 FDA.
Copyright:: The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:: 1 online resource (1 PDF file (4 pages)).
NLM Unique ID:: 9918351285206676 (See catalog record)
Permanent Link:: http://resource.nlm.nih.gov/9918351285206676