Zdrowie i gospodarka · 21/08/2009

FDA to Make Significant Progress Under PDUFA IV

The Food and Drug Administration (FDA) is set to make significant progress in modernizing its regulatory processes and information technology infrastructure under the Prescription Drug User Fee Act IV (PDUFA IV), which was reauthorized in 2007. The agency plans to build on its previous achievements and transform its work environment from paper-based to electronic, with the goal of creating a fully electronic standards-based submission and review environment.