The Biotechnology Industry Organization (BIO) welcomes this opportunity to comment on the success of the Prescription Drug User Fee Act (PDUFA) and the proposed enhancements for PDUFA IV. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. Leveraging recent advances in genomics, proteomics, and bioinformatics, biotechnology researchers are leading the development of novel therapies to treat unmet and under-met medical needs in areas such as Alzheimer’s disease, diabetes, cancer, cardiovascular disease, and many other devastating illnesses. A strong, credible, and efficient Food and Drug Administration (FDA) plays a critical role in enabling BIO member companies’ success in creating the next generation of biotechnology medicines.