Draft guidance on management of rolling reviews for drug submissions: Overview (English, HTML)
View metadata and access the original English HTML file: Draft guidance on management of rolling reviews for drug submissions: Overview.
- Format
- HTML
- Access
- file-only
- Publisher-reported update
- 2023-09-01
This guidance helps sponsors interpret amendments to the Food and Drug Regulations (regulations) that allow a sponsor to apply for rolling review status for a forthcoming drug submission that meets specific eligibility conditions.
Data overview
- Formats
- HTML
- File languages
- English
- Available actions
- Access original file