Zdrowie i gospodarka · 30.06.2008
Prescription Drug User Fee Act IV Information Technology Plan
The Food and Drug Administration (FDA) is announcing the availability of the information technology (IT) Plan entitled "Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan" to achieve the objectives defined in the PDUFA Performance Goals. 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 review process of human drug applications.