WASHINGTON, Aug. 19 -- Food and Drug Administration has issued a notice called: Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Aug. 19 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Approaches to Assessment of Overall Survival in Oncology Clinical Trials." The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approva...