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Regulatory Affairs: The IND, NDA, and Postmarketing

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Overview 

Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of lectures, workshops and online precourse modules. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Course Level: Beginner

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