J. Matthew Luther, MD, MSCI
Associate Professor, Medicine
Associate Professor, Pharmacology
Co-Director, Vanderbilt Program in Molecular Medicine
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.