What guidance will be provided to sponsors to help them prepare quality submissions and thus reduce the likelihood of deficiency notices?
VDD is committed to supporting sponsors in preparing quality, complete submissions. VDD will conduct, as required, workshops or training sessions to help sponsors in the preparation of submissions. VDD is encouraging sponsors to hold pre-submission meetings in order to clarify issues before the submission is filed. The guidance for the Preparation of New Drug Submissions developed in parallel to the MoRS will also significantly help sponsors. The development of additional documents is planned for the future.
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