Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status
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.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
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