The US Food and Drug Administration had to navigate a biologics license application of poor quality in its review and approval of CellTrans, Inc.’s cellular therapy Lantidra (donislecel-jujn) for treatment of type 1 diabetes.
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‘Poor Quality’ Submission: CellTrans’ Lantidra BLA Marked By Missing And Incongruent Data
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FDA's review of documents and source data files to assess product efficacy and subject safety was complicated by missing and inconsistent data, the clinical reviewer said, concluding there was insufficient data monitoring during clinical studies or in preparing the documents for regulatory submission.
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