On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. This new law includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with stable and consistent funding during fiscal years 2013-2017 to maintain a predictable and efficient review process for human drug and biologic products. The PDUFA program has revolutionized the review process in the United States and enabled FDA to help bring to market critical new medicines for patients while maintaining FDA’s high standards for safety, efficacy, and quality. Since its enactment in 1992, PDUFA has produced significant improvements in public health by providing patients with faster access to over 1,500 new drugs and biologics, including treatments for cancer, infectious diseases, neurological and psychiatric disorders, and cardiovascular diseases.
This fifth authorization of PDUFA is embodied by Title I of FDASIA and the performance goals and procedures for PDUFA V which resulted from extensive public input, negotiations with industry representatives, and consultation with public stakeholders that began in April 2010. FDA then transmitted the recommendations for PDUFA V to Congress in January 2012. These enhancements include a new review program for new molecular entity new drug applications and original biologics license applications, proposals to enhance regulatory science and expedite drug development, enhanced benefit-risk assessment, modernization of FDA’s drug safety system, and new requirements for electronic submissions with standardized application data.
These topics and more will be on the agenda of a two-day conference that will provide an opportunity for FDA, industry, patient, consumer, and healthcare professional group representatives, and technology vendors to discuss the key PDUFA V commitments, current plans for their implementation, and potential impact on all stakeholders.
Enhancement and Modernization of the FDA Drug Safety System in PDUFA V
This session will summarize FDA’s commitments to enhance the detection, prevention, and mitigation of drug adverse events. The discussion will include FDA’s plans for standardization of risk evaluation and mitigation strategies (REMS) and increased stakeholder input into REMS development, and exploration of the use of the Sentinel system to evaluate drug safety issues that may require regulatory action. FDA’s augmented internal processes for inter-office, multidisciplinary review and action on, as well as communication about, postmarketing drug safety issues will also be described.
Continuing Education Credits are not Available for Archived Recordings
This Archived Recording was recorded live during the PDUFA V Conference. Subsequently there may be short periods of time where the sound level may vary for any given presentation. During these short intervals, you may want to turn up the speaker volume on your computer.
Multiple speakers participated in each session. Some presenters did not provide slides, so only the audio presentation is available.