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Apr 19, 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 Hours: 3 hrs Grade Mode: Normal (A-F)
Typically offered Fall
Prerequisite(s):
Last Updated: Course Rotation 9/2014, 07/2011; 05/2011
Summer 2024 Course Sections
Fall 2024 Course Sections
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