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A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process

Affiliation of the authors: University of Maryland, Baltimore, Maryland.

Correspondence and reprints: Kip Canfield, PhD, IFSM UMBC, 1000 Hilltop Circle, Baltimore, MD 21250. e-mail: <canfield{at}umbc.edu>.

Abstract This primary goal of this project was to develop a software architecture to support the Food and Drug Administration (FDA) generic drug application process by making it more efficient and effective. The secondary goal was to produce a scalable, modular, and flexible architecture that could be generalized to other contexts in interorganizational health care communications. The system described here shows improvements over the old system for the generic drug application process for most of the defined design objectives. The modular, flexible design that produced this new system offers lessons for the general design of distributed health care information systems and points the way to robust application frameworks that will allow practical development and maintenance of a distributed infrastructure.