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Sponsors can use postmarket adverse event data, drug use data, and observational or epidemiological data, in addition to stakeholder input for their REMS assessments, the agency said. Read More
Medicare and Medicaid beneficiaries received more insulin than they were prescribed, and the company billed the federal programs accordingly. Read More
The FDA should require a Risk Evaluation and Mitigation Strategy to ensure patient use mimics clinical trial conditions, a CDC official said. Read More