USFDA issue new Guidance on Clinical Trial Imaging Endpoint Process Standards

Final Guidance for Industry effective April 2018

The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products.2 This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that we regard as important when imaging is used to assess a trial’s primary endpoint or a component of that endpoint.

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