MPRA-600 The Regulation of Pharmaceuticals
Fall for 2017-2018
This course offers a comprehensive overview of the development of pharmaceuticals and relevant regulations in preclinical programs, clinical research, regulatory submissions, and post-marketing surveillance. Students review FDA regulations for nonclinical testing, clinical testing, good laboratory practices, and the marketing of pharmaceuticals. Related laws such as the Prescription Drug User Fee Act (PDUFA) are reviewed in depth. Students learn to complete processes such as the FDA’s Investigational New Drug Application (IND) and New Drug Application (NDA). By the end of this course, students will understand how to adhere to regulatory and compliance requirements f
Credits: 3
Prerequisites: None
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