Complimentary Webinar: Recent FDA Perspectives on Clinical Outcome Assessments: A Review of 2014 Drug Development Tool and Therapeutic Area Guidance Documents In this webinar, we will review specific elements of the guidance, “Qualification Process for Drug Development Tools” (issued Jan., 2014), which describes a process for the advanced qualification of COAs within a specific context of use. We will contrast the qualification pathway to the process of generating a fit for purpose COA in the context of a specific product development program. Draft guidance documents issued in specific therapeutic areas, including analgesic indications and chronic fatigue syndrome, will also be reviewed.
Posted on: Wed, 30 Apr 2014 17:03:37 +0000
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