This course is designed to provide an understanding of the regulation of drug products by the US Food and DrugAdministration. Among the topics we will explore include discussions of New Drug Applications, Abbreviated New Drug Applications and OTC monographs. We will also examine the areas of patent issues and market exclusivity within the context of FDA regulatory compliance.
Prerequisite: It is recommended that students take PHA 6273/6935 Structure, Process & Outcomes of Regulation prior to taking this course.
PHA 6274 Syllabus