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GlobalSubmit and FDA Partner on eCTD Review.
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PR Newswire
- Article date:
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August 1, 2005
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Copyright informationCOPYRIGHT 2005 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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ROCKVILLE, Md., Aug. 1 /PRNewswire/ -- Under a partnering arrangement, GlobalSubmit, Inc. and the Food and Drug Administration (FDA) are collaborating on the deployment and enhancement of GlobalSubmit software for the review of the Electronic Common Technical Document (eCTD) submissions. During this collaboration, FDA has deployed the GlobalSubmit tool, coined "FDAreview," replacing the FDA's Electronic Common Technical Document (eCTD) Viewing System (EVS).
With the deployment of FDAreview, FDA reviewers are well positioned to handle the high volume of eCTD submissions expected in the upcoming years. Electronic submissions using the eCTD specification provide FDA ...
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