Rolling Submission
An FDA process allowing drug sponsors with Fast Track designation to submit completed sections of their application for review as they become available, rather than waiting until the entire package is complete. Rolling submission can significantly reduce the overall time to approval.
Technical Context
Rolling review (or rolling submission) allows a sponsor to submit completed sections of an NDA/BLA as they become available, rather than waiting until the entire application is complete. This is available to products with Fast Track designation (FDA) or under specific circumstances in the EU (conditional MA, pandemic contexts). The FDA begins reviewing each module as it arrives, potentially saving 2-6 months compared to standard submission where review begins only after the complete application is filed. Rolling review does not change the review clock — the PDUFA goal date is set from the date the final module is submitted (completing the application). For breakthrough therapy-designated peptide drugs, rolling review combined with priority review can significantly accelerate the path from clinical trial completion to approval.