Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation

Catalog description

Offers an overview of biopharmaceutical product formulation, development, and commercialization regulation by the U.S. Food and Drug Administration (FDA) and other regulatory agencies. Through course work and didactic technical instruction, offers students an opportunity to develop the foundations necessary to build a strong scientific and technical understanding of biopharmaceutical design and commercialization compliance. Topics include the dynamic progression of U.S. biopharmaceutical laws, differentiation between law vs. regulation, FDA and industry compliance functions, policy-guided science, and cases that shape the evolution of regulatory compliance.