Case Study

Clinical Trial Imaging Endpoint Process Standards

Clinical Trial Imaging Endpoint Process Standards

Pages 31 Pages

Clinical Trial Imaging Endpoint Process Standards Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2018 Clinical/Medical Clinical Trial Imaging Endpoint Process Standards Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@fda.hhs.gov https://www.fda.gov/Drugs/GuidanceComplia

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