The FDA recently issued a new draft guidance document for clinical trial imaging, Clinical Trial Imaging Endpoint Process Standards; Draft Guidance for Industry. This new guidance is intended to address some of the challenges concerning the standardization of medical imaging in clinical trials. The HIRO submitted a comment to the FDA regarding these guidelines in 2016, and the comment was recently accepted and posted. We hope you had a chance to weigh in on this important issue as well!

News item updated on 2017-02-01 09:45 -0500.