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Zdrowie i gospodarka · 28/12/2007

Draft Prescription Drug User Fee Act IV 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 "Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan." This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications to achieve the objectives defined in the PDUFA Performance Goals.

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