NIH Clinical Center: FDA Regulatory Process for Clinical Investigators

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FDA Regulatory Process for Clinical Investigators

This course is an elective component of the curriculum in clinical research established by the National Institutes of Health (NIH) Clinical Center's Office of Clinical Research Training and Medical Education. The course was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and originally taught in 2005 by experts from the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). Another workshop was held in 2007 taught by experts from the Center for Drug Evaluation (CDER) at the FDA. Because the principles are broadly applicable to all investigators, the NIH Clinical Center has partnered with the FDA and NIAID to provide this course to you electronically. We feel that an understanding of these concepts is critically important, and our objective in these series of recorded sessions is to provide the core background information in a focused and organized manner to make the educational process as easy and accessible as possible.