Practical Guidance for Successful BLA Submissions from a Statistician’s Perspective

• Activity Number: 385 - Biomarkers, Endpoint Validation and Other Topics
• Type: Contributed
• Date/Time: Thursday, August 12, 2021 : 12:00 PM to 1:50 PM
• Sponsor: Biometrics Section
• Author(s): tulin shekar*
• Companies: Merck
• Keywords: Guidance; BLA; electronic submission (eSubmission); CTD components

Abstract

This paper describes lessons learned from recent Biologics License Application (BLA) submissions. Paper provides an overview of submission packages and requirements by Federal Drug Agency (FDA). A successful BLA submission can be achieved with careful planning, persistent adherence to the plan, and a collaboration between team members. This paper focuses on the clinical section of the common technical document (CTD) components and data submission and tips on how to avoid technical rejection. Paper includes tips on planning, content, technical issues, and FDA interactions based on our experience and a literature review.