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Published on: December 11, 2016
A case study of the evolving software architecture for the FDA generic drug application process
K Canfield1, M Ritondo, R Sponaugle
1University of Maryland, Baltimore, USA. canfield@umbc.edu
Journal of the American Medical Informatics Association : JAMIA
|October 7, 1998
Summary
A new software architecture enhances the Food and Drug Administration (FDA) generic drug application process. This modular design improves efficiency and offers a flexible framework for distributed healthcare systems.
Area of Science:
- Health Informatics
- Software Engineering
- Regulatory Science
Background:
- The existing generic drug application process at the Food and Drug Administration (FDA) faced challenges in efficiency and effectiveness.
- Interorganizational healthcare communications require scalable, modular, and flexible information systems.
Purpose of the Study:
- To develop a software architecture for the FDA generic drug application process, aiming for increased efficiency and effectiveness.
- To create a scalable, modular, and flexible architecture applicable to broader interorganizational healthcare communication contexts.
Main Methods:
- Design and implementation of a novel software architecture.
- Evaluation of the architecture against defined design objectives for the generic drug application process.
Main Results:
- The new system demonstrates significant improvements over the previous system for the generic drug application process.
- The architecture meets most of the defined design objectives, indicating enhanced performance and usability.
Conclusions:
- The developed modular and flexible architecture offers a robust framework for the generic drug application process.
- Lessons learned from this project are applicable to the general design of distributed healthcare information systems and infrastructure development.
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