Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status (English, HTML)

View metadata and access the original English HTML file: Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status.

Format

HTML

Access

file-only

Publisher-reported update

2023-09-01

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.

Access original file