FDA eTransformation

Axendia has recently completed a research study on FDA’s e-Transformation Initiatives. The study identified key organizational and technology initiatives the Agency is undertaking to advance ongoing electronic communication and interactions with the companies it regulates. 

We are sharing key insights and conclusions from the “FDA e-Transformation Initiatives” research study in a series of articles.  

Part I:

To understand the Agency’s rationale and strategy for e-Transformation, we begin this series by sharing our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics.  During our conversation, Dr. Oliva discusses transformational activities that promise to usher a new era of electronic interactions between the Agency and its constituents. 

Click on this link to read Part I

Part II:

In the second installment of the “FDA e-Transformation” series, we highlight four key findings from this study: 

  • FDA’s e-Transformation drivers
  • A new organizational e-Structure
  • Don’t want to pave the cow-path
  • Building  on a strong foundation: open-consensus based data standards

Click on this link to read Part II

Part III 

In the third installment, we report on the FDA’s Target Enterprise Architecture.

To meet its e-Transformation objective, the Agency is poised to deploy a new Target Enterprise Architecture (EA). This Target EA will provide a business-driven plan that describes the desired end-state for the FDA’s business architecture, data architecture, applications architecture, technical architecture, security architecture, and standards profile.

Click on this link to read Part III

White Paper:

To download the Whitepaper based on this research, click on this link:  eFDA-White-Paper-Axendia-Final.pdf

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc.

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com

Copyright 2009 Axendia, Inc. All Rights Reserved.
No Portion of this publication may be duplicated or redistributed in any form without approval from Axendia.