What action will restart the review clock after receiving a non-approval letter for a BLA?

Submitting the complete response is the action that will restart the review clock after receiving a non-approval letter for a Biological License Application (BLA). A complete response typically addresses the deficiencies noted in the non-approval letter and demonstrates how the applicant intends to remedy those issues. Once this response is submitted, the FDA can resume its review process, during which it will assess the new data and information provided.

Requesting a meeting with the FDA or filing an appeal does not directly restart the review clock. While these actions might be part of the overall strategy for addressing a non-approval letter, they do not trigger the formal review process on their own. Additionally, waiting for the FDA to initiate a new review is not proactive; restarting the review process depends on the applicant providing the complete response that the FDA requires to review the application anew.