Draft guidance on management of rolling reviews for drug submissions: Overview

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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Title (French) Ébauche des lignes directrices sur la gestion des examens en continu pour les présentations de drogues : Aperçu
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
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Data Dictionary
Open Canada Date Published 2023-01-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["présentations de médicaments", "gestion des examens continus", "aperçu des présentations de médicaments"], "en": ["drug submissions", "management-of-rolling reviews", "drug submissions overview"]}
Open Canada Collection publication
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