WASHINGTON--(BUSINESS WIRE)--Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the transmission of the Prescription Drug User Fee Act (PDUFA) V recommendations by the Secretary of Health and Human Services to Congress today:
“Since PDUFA was enacted in 1992, it has contributed to the approval of more than 1,200 new medicines and initially reduced review times for the newest, most innovative drugs by more than a year. BIO strongly supports the PDUFA V recommendations as they will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, PDUFA V will provide patients and doctors with earlier access to innovative new therapies.
“Since PDUFA was enacted in 1992, it has contributed to the approval of more than 1,200 new medicines and initially reduced review times for the newest, most innovative drugs by more than a year. BIO strongly supports the PDUFA V recommendations as they will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, PDUFA V will provide patients and doctors with earlier access to innovative new therapies.
