Title: FDA drug approval intervals from 1997 to 2006: analysis and comparison during information technology implementation

Authors: John F. Kros, Christopher M. Keller

Addresses: College of Business, East Carolina University, 3121 Harold Bate Building, Greenville, NC 27858, USA. ' College of Business, East Carolina University, 3136 Harold Bate Building, Greenville, NC 27858, USA

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.

Keywords: Food and Drug Administration; US FDA; drug review times; drug approval; drug development; information technology; electronic healthcare; e-healthcare; USA; United States; new drug applications.

DOI: 10.1504/IJEH.2009.029223

International Journal of Electronic Healthcare, 2009 Vol.5 No.2, pp.164 - 176

Published online: 10 Nov 2009 *

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