title: FDA drug approval intervals from 1997 to 2006: analysis and comparison during information technology implementation.
abstract: The implementation of new Information Technology (IT) has been a persistent target for improving FDA review intervals. Three main categories of new drugs are studied: New Drug Application (NDA), the Supplemental New Drug Application (SNDA) and the Abbreviated New Drug Application (ANDA). This paper finds that the median review time for an ANDA was significantly longer than that of an NDA and SDNA. A comparison of application class medians revealed significant differences. Regardless of the recent focus on IT implementations at the FDA pertaining to review intervals, that focus has not yet yielded a statistically significant improvement in review times.
authors.affiliation: College of Business, East Carolina University, 3121 Harold Bate Building, Greenville, NC 27858, USA. krosj@ecu.edu
authors.forename: John F
authors.initials: JF
authors.lastname: Kros
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Keller
mesh_terms: D004059:Diffusion of Innovation; D017277:Drug Approval / Q000458:organization & administration*; D017598:Efficiency, Organizational; D007256:Information Systems; D014481:United States; D014486:United States Food and Drug Administration