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Description: Appendix 6a: Notice of Compliance with Conditions (NOCc) Consideration upon Completion of a New Drug Submission (NDS) or Supplement to a New Drug Submission (SNDS) Review

Sponsors file the submission; however, consideration under the Notice of Compliance with Conditions policy is not pursued at the outset. The submission undergoes screening. Screening time is 45 days following 10 days of processing, or 25 days following 10 days of processing days for Priority Submissions. If the submission is not accepted for review, a screening deficiency notice may be issued. If the submission is accepted at screening, then submissions which were granted priority review status will undergo a shorter review timeframe (target is 180 days). If the sponsor did not request and complete an application for priority review status or it was not granted, then the review target will be 300 days. Please note that priority review status will only be granted before the submission has been filed. Possible outcomes following review are: NOC (without conditions), NON, NOD, or an NOC/c-QN. If the outcome of the review is an NOC/c- QN, the response to QN must be filed within 30 days (with a review target of 30 days), upon which the NOC with conditions may be granted.