Jan 28, 2026  
2020-2021 Graduate Catalog 
    
2020-2021 Graduate Catalog This is not the most recent catalog version; be sure you are viewing the appropriate catalog year.

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


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