The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Biocon Biologics’ Biologics License Application (BLA) for its Insulin-R product. The CRL cites the need for additional data in the BLA submission and expects a satisfactory implementation of a Corrective Action and Preventive Action (CAPA) plan related to the Pre-Approval Inspection of Biocon Biologics’ Bangalore facilities in August 2022. The company is currently working on addressing the CRL.” – Company Spokesperson, Biocon Biologics.
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