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Zdrowie i gospodarka · 27.04.2018

Clinical Trial Imaging Endpoint Process Standards; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Clinical Trial Imaging Endpoint Process Standards." This guidance assists sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that FDA regards as important when imaging is used to assess a trial's primary endpoint or a component of that endpoint. This guidance finalizes the draft guidance of the same name issued on March 5, 2015.

Source: Federal Register — Food and Drug AdministrationOpen original release →