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

Event

FDA Convening

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

August 20, 2024 — 9:30AM–4:15PM

Hybrid - National Press Club, Washington D.C.

Contact Information

Luke Durocher

margolisevents@duke.edu
Event Graphics Including Name Time and Date of Event

 

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 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 

This meeting is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [U19FD006602] totaling $5,192,495  with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Please use the button on the right to register at attend in-person.
Please use the button on the right to register at attend virtually.

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

 

Questions and Comments

 
If you have a question you would like to submit for consideration during this event, you may submit using the form below.

Organization Type
1) Have you or your organization submitted a BLA for an original or biosimilar product?