Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities On June 12, 2019, under a cooperative agreement with the FDA and in partnership with the Critical Path Institute, the Robert J. Margolis, MD, Center for Health Policy at Duke University will convene a public workshop to consider key implementation challenges and potential opportunities to advance the development and application of analysis data standards. This public workshop is being organized to fulfill FDA’s commitment as part of the Prescription Drug User Fee Reauthorization Act for Fiscal Years 2018 through 2022 (PDUFA VI goals letter) to convene a public workshop to advance the development and application of analysis data standards. Feedback from this workshop will inform ongoing and future analysis data standards initiatives at FDA as well as strategic planning efforts to improve regulatory review of electronic submissions.
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