Draft guidance on management of rolling reviews for drug submissions: Overview (French, HTML)

View metadata and access the original French HTML file: Draft guidance on management of rolling reviews for drug submissions: Overview.

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HTML

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Publisher-reported update

2023-09-01

This guidance helps sponsors interpret amendments to the Food and Drug Regulations (regulations) that allow a sponsor to apply for rolling review status for a forthcoming drug submission that meets specific eligibility conditions.

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