WASHINGTON--(BUSINESS WIRE)--The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.
