Submitting Periodic E2B Report Submissions to FDA

(Doc ID 1426245.1)

Last updated on JULY 05, 2017

Applies to:

Oracle Argus Safety - Version and later
Information in this document applies to any platform.

***Checked for relevance on 24-JUL-2014***


Please provide us the detailed approach of how to make Electronic Submissions of Periodic reports (PSUR & USPR) to FDA


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