Introduction to Drug and Medical Device Regulation
RGA6100 / 4 q.h.
Formerly RA 3100.
Provides an overview of drug, biologics, and device development and the FDA. Through course work and discussion, offers students an opportunity to gain the foundations necessary to build a strong understanding of regulatory affairs. Topics include the historical development of U.S. drug laws, law vs. regulation, FDA and industry functions, policy-guided science, and cases shaping history into the present state of regulation.
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