The FDA is currently implementing numerous systems which promise to usher in a new era of electronic interactions between the agency and its constituents (i.e. industry and consumers).
A research study on "FDA's e-Transformation Initiatives" by industry analyst firm Axendia identified key organizational and technology initiatives the Agency is undertaking to advance this electronic transformation.
According to Dr. Oliva, "...it's fair to say that Agency is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn't tell when that is going to happen, but certainly there are active discussions underway to move to an all electronic submission environment for all FDA regulated product information whether it be, product quality, manufacturing, pre-market or post-market data."
For a complete transcript of the interview with Dr Oliva, additional findings and analysis on this study as well as a related white paper please visit: www.axendia.com/eFDA.
To learn more about Axendia visit www.axendia.com.Share This Article
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