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Regulatory Affairs Part II: The NDA Phase

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Overview 

Learn about US Food and Drug Administration (FDA) regulations and expectations for the content, submission, and review of new drug applications (NDAs) and the importance of regulatory strategy. This blended learning opportunity features two archived online courses focusing on fundamental concepts, followed by a training course consisting of interactive lectures and hands-on workshops. Learn about FDA history, regulations, roles and responsibilities, and organization relative to the development of pharmaceuticals and biologics in the United States. Learn the processes characteristic of pharmaceutical and biologic product discovery, development, and commercialization.

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