Regulatory Writing: New Drug Applications
TCC6380 / 4 q.h.
Formerly PW 3399.
Examines the process of writing drug submissions for regulatory agencies both nationally and internationally. Topics include drug regulations, the drug development process, and clinical study documents. Offers students an opportunity to practice communicating complex scientific information in various documents, including investigators’ brochures, clinical trial reports, and IND/NDA submission components.
There are no current sections scheduled for this course number. Please note that courses have been assigned new numbers beginning with the fall term. Please check the new course number for course availability.
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