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.
To find more information please use the below mentioned weblink
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