RGA 6380 — Advanced Regulatory Writing: New Drug Applications
4 semester hoursGraduateLecture
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 Investigational New Drug (IND) application submission components.