ABSTRACT
Drug User Fee Act of 1992 (PDUFA), which permitted the FDA to collect fees to enhance the review process. PDUFA was reauthorized as part of the Food and Drug Administration Modernization Act of 1997 (PDUFA II), and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PDUFA III), both of which amended the FD&C Act and the PHS Act. The implementation of the PDUFA has resulted in establishing timelines and performance goals for identified review activities conducted by the FDA, provided for additional guidelines for meeting with industry, as well as provided for fees (user fees) to support FDA’s review of marketing applications. The implementation of these timelines and fees is intended to increase the transparency by which the FDA conducts its review and to facilitate the timeliness of product development and licensure.
