FDA’s Data Format Standards Approaching Cost-Benefit Analysis Stage
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency sets a meeting for November and wants comments in advance on potential candidates for a format that will reduce the need for data integration steps between its various systems.
You may also be interested in...
First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It?
FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.
FDA Data-Standards Landslide: CDISC’s Model Wins Docket Comment Contest
Overwhelming number of stakeholders urge FDA to choose the Clinical Data Interchange Standards Consortium’s Operational Data Model instead of the competing Health Level 7 standard for clinical data submissions.
Critical Path Institute’s New Business Model: An Interview With CEO Compton
After six months on the job, Carolyn Compton, the institute’s new chief executive, has overhauled the funding rules to allow fees from big pharma to cover overhead as government funding dries up. Successor to founder Raymond Woosley, who retired last year, Compton shares her vision for securing the institute’s finances for the future amid tough economic times.