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 the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.
This is the fifth authorization of PDUFA that includes Title I of FDASIA and the performance goals and procedures for PDUFA V. As directed by Congress in the FDA Amendments Act of 2007, FDA developed the proposed enhancements for PDUFA V in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders from July 2010 through May 2011. FDA transmitted these proposed enhancements to Congress on January 13, 2012 which are referred to in Title I of FDASIA.
The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2013-2017 that will allow the agency to fulfill its mission to protect and promote public health by helping to bring to market critical new medicines for patients. This page contains the relevant information related to PDUFA V and FDA’s implementation of the PDUFA V enhancements.
PDUFA V Implementation
PDUFA V Commitment: Assessment of Sentinel System’s Strengths, Limitations, and Appropriate Use PDUFA V Information Technology/Informatics Plan FY 2013 – FY 2017(PDF - 447KB) Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs
- Enhancing Benefit-Risk Assessment in Regulatory Decision-Making
Enhanced Communication REMS Integration Initiative Enhancing Regulatory Science - Methodologies for Meta-Analysis