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changes.mady.by.user Steve Kopko

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BEFORE POSTING FOR PUBLIC REVIEW

  •  All internal review comments have been resolved and updated in JIRA.
    •  in-line comments need addressing - Done
  •  Supplement has been through copy-editing.  This will be moved to copy-editing after comments are addressed.
  •  The FDA priority list has been checked to see if the supplement is marked "yes".
    •  Not an FDA priority
    •  If the supplement is an FDA priority, it has gone through FDA review and additional copy-editing if there were extensive changes.  This will need to go through copy-editing and then to the FDA for review (if they still want to review this version).
  •  The FDA disclaimer is in the supplement if they reviewed it and not in the supplement if it's not an FDA priority.
  •  Notify the SDS QRS Subteam that the supplements are ready for public review.
  •  Announcement has been prepared.
  •  Project Manager/Team Lead notified Ann White (Communications) at least 5 days before planned public review posting so she can review the announcement and post to the CDISC website.

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