FDA Meets Fewer PDUFA Dates in Fiscal 2008

Although the FDA has increased staff and advisory committee meetings, the percentage of NDAs and BLAs the agency reviewed by Prescription Drug User Fee Act (PDUFA) deadlines in fiscal 2008 declined from the previous year. In fiscal 2008, the FDA reviewed 84 percent of standard NDAs and BLAs by their PDUFA date compared with 88 percent in 2007, John Jenkins, director of the FDA’s Office of New Drugs (OND), says in a presentation posted on the agency’s website.
Drug Industry Daily