Description
To apply for rolling review status for a forthcoming new drug submission (NDS) or supplement to a new drug submission (SNDS), sponsors must provide a Rolling Review Application Package (RRAP). The RRAP is forwarded to the appropriate directorate and assessed within 45 calendar days.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status | HTML | Open resource | |
| Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status | HTML | Open resource |