Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection: CMC for Biologics & Biosimilars

During this hybrid public meeting, FDA, sponsor companies, and other experts will explore the root causes of Complete Responses (CRs) related to quality and facility issues for CDER regulated original and biosimilar Biologic Licensing Applications (BLAs). The recent rate of CRs for BLAs may be attributed to various factors which include quality and facility issues. CRs can result in delayed access to treatment for patients and additional time and resource demands for FDA and sponsor companies.

This event is open to all.
This meeting will seek to identify opportunities and strategies to improve regulatory submissions and enhance regulatory assessment of BLAs. Topics will include:

- Common and recurring data, submission, and facility issues
- Opportunities to improve communication between sponsors, contract manufacturing organizations, FDA, and other relevant stakeholders
- Lessons from BLA successes