Final Guidance Document Data Requirements for Safety and Effectiveness of Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis for Industry

Final Guidance Document Data Requirements for Safety and Effectiveness of Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis for Industry This guidance is intended to assist sponsors in the collection and analysis of data for Steroid Nasal products for use in the treatment of allergic rhinitis, in order to meet the safety and effectiveness requirements under Part C, Division 8 of the Food and Drug Regulations. 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentdata requirementssafety and effectivenesssteroid nasal productstreatment of allergic rhinitisFood and Drug Regulations Final Guidance Document Data Requirements for Safety and Effectiveness of Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis for IndustryHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/inhalers/release-final-guidance-document-data-requirements-safety-effectiveness-subsequent-market-entry-steroid-nasal-products-use-treatment-allergic-rhinitis.html Final Guidance Document Data Requirements for Safety and Effectiveness of Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis for IndustryHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/aerosol/publication-version-finale-ligne-directrice-exigences-relatives-innocuite-efficacite-steroides-pulverisation-nasale-commercialisation-subsequente.html

This guidance is intended to assist sponsors in the collection and analysis of data for Steroid Nasal products for use in the treatment of allergic rhinitis, in order to meet the safety and effectiveness requirements under Part C, Division 8 of the Food and Drug Regulations.

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