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What happens to submissions in progress at the time the MoRS is implemented?

April 26, 2017happens implemented mors progress submissions time

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What happens to submissions in progress at the time the MoRS is implemented?

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• Submissions with outstanding additional data letters (ADLs) will continue to be subject to the existing Additional Data Letter (ADL) policy. Subsequent Notice of Deficiencies (NOD) issued after July 1, 2005 will be subject to the MoRS. • For existing submissions, accepted for review but for which the review has not been completed, the VDD will endeavour to uphold the intent of the MoRS i.e., synchronize the review streams and issue a single NOD if necessary. However, if the different review streams for a submission are projected to be completed more than 90 days apart, separate NODs will be issued for the submission.