The FDA is charged with assuring the safety and efficacy of new drugs while also making them available to the public as quickly as possible. To help meet these competing pressures, Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992.  This Act imposed performance goals on the FDA and allowed it to levy fees on pharmaceutical firms to provide the resources necessary to meet those goals.  Although Congress has renewed PDUFA twice since it originally passed, there is little evidence on its effectiveness.  This Joint Center conference will present and critically review some of the first empirical research on the impact of PDUFA on drug approval times.