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.
Facility Deficiencies Drive Rising CRL Rates For CDER Biologics
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.
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