Temple University 3 credits QARA
This course reviews the regulatory and legal fundamentals of labeling FDA-regulated products, specifically, prescription pharmaceuticals, emphasizing the direct application of the regulations to actual practice. It analyzes case studies and current practices, providing an overview of legal, regulatory, and marketing concepts affecting labeling. It discusses the application of current knowledge and explores new trends in the legal and regulatory framework surrounding the development and implementation of drug labeling. As a class project, students are assigned to drug development teams (Regulatory Affairs, Marketing and Clinical) and provided with the known data of their compounds. Teams determine what information is needed to complete the draft labeling for NDA submission, and develop a final label; they hold mock negotiations (internal and with the Agency) and propose changes to labeling in response to post-marketing surveillance.
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