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