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Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 
• By Bridget Silverman

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

bioreactor
The complexity of advanced biologic manufacturing can delay US FDA approval. • Source: Shutterstock

Manufacturing facility issues were the most common deficiencies seen in the increasing number of complete response letters for biologics issued by the US FDA’s Center for Drug Evaluation and Research, according to an early analysis of 10 years of biologic license application approvals.

Key Takeaways

  • An FDA analysis of more than 100 BLA complete response letters issued by CDER provided a glimpse into the factors contributing to their increase.

  • Manufacturing facilities, especially contract manufacturing facilities, were among the fastest-growing topics, followed by product quality and microbiology

CDER’s Office of Pharmaceutical Quality analyzed more than 100 complete response letters issued for CDER BLAs from 2014-2024, FDA Senior Pharmaceutical Quality Assessor Maxwell Van Tassel told a 20 August Duke-Margolis Institute for Health Policy meeting on

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