21 May 2012
THE eCTD SUMMIT: How the FDA uses REVIEW and VALIDATE
Besides loading and validating submissions, VALIDATE is used to reject submissions for technical reasons. If VALIDATE reports a high error, your submission could be rejected. This rejection could take up to five days to be reported. When an original or supplement is rejected, your PDUFA time clock will not start.
Some divisions in the FDA have what is called an integrity reviewer. The integrity reviewer uses the VALIDATE report with REVIEW to ensure the submission is reviewable. This reviewer checks for many deficiencies, including but not limited to, broken hyperlinks, missing content, and STF files that are provided.
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