Zdrowie i gospodarka · 21/08/2009

Prescription Drug User Fee Act IV Information Technology Assessment

In the last decade, the Food and Drug Adminstration (FDA) has achieved great success in reforming and modernizing its regulatory processes and responsibilities as a result of changes and improvements driven by the requirements of the Prescription Drug User Fee Act (PDUFA), the 1997 FDA Modernization Act (FDAMA), and other legislation. PDUFA was reauthorized by the Food and Drug Administration Amendments Act of 2007, Title I, Prescription Drug User Fee Amendments of 2007 (PDUFA IV). FDA plans to make even greater progress during the PDUFA IV timeframe (Fiscal Years 2008 through 2012), building on the foundation established in previous years. The additional resources provided by user fees, when combined with appropriations, have enabled the FDA to modernize its information technology infrastructure and begin a monumental transformation from a paper-based to an electronic work environment. As part of the PDUFA IV commitment, FDA published the PDUFA IV Information Technology (IT) Plan for comment to allow the public to provide feedback as FDA moves towards a fully electronic standards- based submission and review environment. FDA reviewed the comments, updated the plan, and published t