Measuring the Pace of New Drug Development in the User Fee ERA

The Prescription Drug User Fee Act of 1992 (PDUFA) is credited with the dramatic reduction in new drug approval times seen since 1993. Despite the faster approval times, however, the total time required for new drugs to reach the marketplace had not changed appreciably. With passage of the FDA Modernization Act of 1997 (FDAMA), the United States Food and Drug Administration (FDA) expanded its focus from shortening the regulatory review phase to...