Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibility (English, HTML)

View metadata and access the original English HTML file: Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibility.

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Publisher-reported update
2023-09-01

Health Canada is offering an option for a rolling review of a new drug submission (NDS) or supplement to a new drug submission (SNDS) that meets specific eligibility conditions. Sponsors nearing the end of clinical development of a drug can apply to Health Canada for rolling review status for a forthcoming drug submission.

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