Zdrowie i gospodarka · 19.09.2011
Prescription Drug User Fee Act IV Information Technology Plan
The Food and Drug Administration (FDA) is announcing the availability of an updated information technology (IT) plan entitled "PDUFA IV Information Technology Plan" (updated plan) to achieve the objectives defined in the Prescription Drug User Fee Act (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 process for the review of human drug applications. The FDA is publishing the updated plan for comment to allow the public to provide feedback as the Agency moves towards a fully electronic standards-based submission and review environment.