PHA 6274 Federal Regulation of Drugs & Pharmacy

Description

This course is designed to provide an understanding of the regulation of drug products by the US Food and Drug Administration.  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.

Tuition: $2,250
Credits: 3


*Please note that this syllabus is subject to change. Use the updated syllabus in Canvas as the official course syllabus.