This course will provide an overview of the U.S. Food and Drug Administration (FDA) by describing the basis for FDA regulation of the development, production, and the approval processes for drugs, devices, and biologics. Offers an opportunity to study FDA standards and to develop the foundations necessary of scientific and technical basic understandings of the drug discovery, testing, reporting, manufacturing, and commercialization. Examines the steps in the development and regulation process within the governing FDAs regulatory centers, and ensures overall compliance with policies, laws, and the evolving regulations.
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