The Future Of The FDA: Operating In An "Electronic World"

By Daniel R. Matlis

Over the past few years, the FDA and the industries it regulates have recognized the need for a modern, well-integrated, reliable, efficient and affordable electronic information infrastructure to support FDA administrative, regulatory and business operations.

This whitepaper discusses FDA transformational activities that promise to usher in a new era of electronic interactions between the agency and its constituents, and is based on primary research conducted by Axendia Inc. and commissioned by MasterControl.

The benefits of the FDA’s e-transformation could be “game changing”. Imagine conducting a label negotiation in real-time with FDA review staff, being able to cooperate and mark up documents in real time, or the possibility of reviewing SOPs and batch records electronically with an investigator. The agency’s move toward an electronic world where all regulated product information comes in electronically is already underway.