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US FDA drafts 5-yr plan to strengthen e-submission of drug applications, data

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration is inviting feedback on a range of IT-related initiatives that it plans to undertake over the next five years to support the review of prescription and generic drug applications1,2. Among other things, the agency plans to implement by June 2014 certain changes to the electronic common technical document or eCTD that is used by drug companies for making regulatory submissions.

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