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Zdrowie i gospodarka · 26.12.2013

Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled "GDUFA Information Technology Plan." This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.

Source: Federal Register — Food and Drug AdministrationOpen original release →