Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection скачать в хорошем качестве

Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection

During this public meeting, FDA, sponsor companies, and other experts explores 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 sought to identify opportunities and strategies to improve regulatory submissions and enhance regulatory assessment of BLAs. Topics included: 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 was 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.