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J. Matthew Luther, MD, MSCI

Associate Professor, Medicine
Associate Professor, Pharmacology
Co-Director, Vanderbilt Program in Molecular Medicine
Associate Director, Vanderbilt Diabetes Research & Training Center, Metabolic Physiology Shared Resource (MPSR)

This seminar styled course is designed to provide an overview of the drug and device development process and will include issues of drug discovery, pre-clinical drug development, Phase I through IV human testing, device development and the role of the FDA in regulatory affairs. Learning objectives will include: 1. To provide an overview of the drug development process from initial compound discovery, through clinical trials, to post-marketing issues; 2. To provide an overview of device development, and to contrast this to the process of drug development; 3. To provide some insight into the function of the Food & Drug Administration (FDA); 4. To discuss topical issues related to drugs, devices, and the FDA by using current events in the news.

Summer [3]