Description

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.

Resources

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

Tags

Topics

Categories