Zdrowie i gospodarka · 14/11/2018

FDA Announces Draft Guidance for Metastasis-Free Survival Endpoint in Nonmetastatic, Castration-Resistant Prostate Cancer Clinical Trials

The FDA has released a draft guidance for industry outlining recommendations for using metastasis-free survival as an endpoint in clinical trials for nonmetastatic, castration-resistant prostate cancer drug development programs, which are overseen by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.