Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma

Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma This guidance document provides sponsors of subsequent entry inhaled corticosteroid (ICS) products for the treatment of asthma with information on the comparative clinical data requirements in order to establish the safety and effectiveness of their products under Section C.08 of the Food and Drug Regulations. 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentdata requirementssafety and effectivenessinhaled corticosteroid productsasthmatreatment of asthmaclinical data requirements Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of AsthmaHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/inhaled-corticosteroid-notice.html Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of AsthmaHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/annonces/avis-corticosteroides-inhales.html

This guidance document provides sponsors of subsequent entry inhaled corticosteroid (ICS) products for the treatment of asthma with information on the comparative clinical data requirements in order to establish the safety and effectiveness of their products under Section C.08 of the Food and Drug Regulations.

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