And....I would hope to say the "safety area" includes the new software data mining package, Sentinel, that is due to come on line...and it's only normal that the process is going to take a bit more time as there will be more information available for can be great, but also bear in mind the influx of additional intelligent information that will be flowing in to the pipeline...more data and better decision making processes...hopefully the clinical trials outside the US will also be able to communicate their offerings and findings...and then it is up to the FDA to determine what is considered credible and useful to make their final decisions...big welcome to the FDA to the world of real time clinical information...BD 

"We have to change ... We have gotten that message loud and clear from the public," Woodcock said.

But, she added: "We are not losing our emphasis on drug development."

Woodcock also said the agency was concerned about the safety impact of the growing number of clinical trials being conducted outside the United States by drugmakers.

FDA official sees some delays over safety | Health | Reuters


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