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US FDA to propose new rule, guidance on e-submission of all drug study data

This article was originally published in SRA

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Executive Summary

The US Food and Drug Administration plans to propose by mid-2012 a new rule that would require drug companies to use an electronic format to submit all the study data that they include in their marketing applications1,2.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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