Policy Issues: Filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug Submissions, Notifiable Changes and Cross-referenced Submissions (English, HTML)

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HTML

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Publisher-reported update

2023-09-03

The attached policy has been developed to provide for the filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug Submissions, Notifiable Changes and Cross-Referenced Submissions in some circumstances prior to the issuance of the Notice of Compliance for the original submission.

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