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.
- Publisher
- Health Canada
- Resources
- 2
- Catalogue metadata updated
- 2021-06-01
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma (French, HTML) HTML
- Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma (English, HTML) HTML