Biologics License Application, BLA submission, 351(a), 351(k)

With the evolving Regulatory enforcement for advanced therapies such as cellular and gene therapy products and other complex biologics/biosimilars that require extensive evaluation of the quality, safety, and efficacy aspects of drug products, Health Authorities have started implementing risk-based review procedures for Biologics License Applications (BLAs) approval. As a result, there might be chances of missing out on mandatory information in the BLAs that could lead to a Refuse-to-File (RTF) action by the US FDA. Therefore, BLA sponsors prefer to be associated with a substantial Regulatory partner with significant experience in Regulatory consulting for Biologics and Biosimilar products.