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Nov 23, 2024
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CLRA 582 - Regulatory Affairs in Drug Development II This course is part of a 3-course sequence that provides a working knowledge of pharmaceutical regulatory affairs. Emphasis is on US development, although topics will include non-US development and the development of biologics, OTC and devices. This course focuses on marketing application (NDAs), labeling, marketing approval and product launch.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Fall
Prerequisite(s) CLRA 581 Updates Course Rotation added 9/2014, 7/2011; 5/2011
Winter 2025 Course Sections
Fall 2024 Course Sections
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