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Jan 02, 2025
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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 Normal (A-F)
May not be repeated for additional credit
Course Rotation - Fall
Prerequisites - CLRA 581
Other Restrictions -
Restriction by Major -
Restriction by Degree Type -
Additional Information:
Updates: Course Rotation added 9/2014, 7/2011; 5/2011
Winter 2025 Course Sections
Fall 2024 Course Sections
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