Abstract

Over the last two decades, the Food and Drug Administration (FDA) has adopted several initiatives designed to speed the approval of new drugs. In the 1970s, the agency implemented a therapeutic rating system and developed procedures for hold ing end-of-phase II conferences. More recently, the agency has expanded the use of computer-assisted new drug applications and has begun holding New Drug Applica tion (NDA) days. This paper examines the impact of these initiatives on drug review times. Results suggest that in general the earlier initiatives are associated with reduced review times for therapeutically important drugs. Despite the FDA's limited experi ence with the more recent initiatives, preliminary results suggest the potential for speeding the new drug review process.