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The manufacturer relied on certificates of analysis from unqualified suppliers instead of testing the attributes of incoming raw materials used in manufacturing. Read More
Participants in the pilot program agreed to provide information on how they develop, test and maintain their software products and on their quality management systems. They also committed to being available for site visits from agency officials. Read More
Regulators based the full authorization on a Phase 3 clinical trial. In the trial, Blincyto showed a superior improvement over standard of care chemotherapy. Read More