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9, Sanofi-Synthelabo has delivered all of its Item 11 components for a new drug application to the FDA in electronic format. While the product delivered was compliant with the guidance set forth by the agency, the technologies and methodologies used by the company varied from project to project. In 2003, a diverse working group was formed to standardize the method used by the Biostatistics organization when producing an electronic submission. This group s primary goals were the standardization.

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