WebA CSR is a report of an individual study of investigational medicinal product conducted in an trial subjects, in which the clinical and statistical description, presentations, and analyses are integrated 1 1.4. What is the aim of a CSR? WebThe CSRs are made up of summaries of clinical information used in making market approval decisions, and were included in the information posted at the drug’s entry at Drugs@FDA. CDER’s goal ...
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