Comments on BsUFA Reauthorization

BsUFA III offers an opportunity for stakeholders to work together to create a BsUFA program that builds on the successes of the first two cycles by strengthening foundational elements and enhancing regulatory review processes to provide increased efficiency and stability to the program. In addition to BsUFA-specific enhancements, there is also an opportunity to support a coordinated approach to key cross-Center and cross-user fee initiatives underpinning the human drug review program.