Guidance Document: Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma
Description
This guidance is intended to assist sponsors in the collection and analysis of comparative clinical data for Inhaled Corticosteroid (ICS) products used for the treatment of asthma that contain the same medicinal ingredient and have the same conditions of use as the Canadian Reference Product (CRP) in order to meet the safety and effectiveness requirements under C.08 of the Food and Drug Regulations [Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3)].
Resources
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Format |
Description |
Link |
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21 |
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https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/profile-corticosteroides-inhales/ligne-directrice-corticosteroides-inhales.html |
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21 |
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https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/inhaled-corticosteroid-profile/inhaled-corticosteroid-guidance.html#a1 |