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Regulatory affairs are comprised of the rules and regulations that govern product development and post-approval marketing. In the U.S., the FDA establishes and oversees the applicable regulations under several statutes, many regulations, and partnerships with legislators, patients, and customers. Biotechnology products may be classified as drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA and its effect on product development. Topics include RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GLP, GCP, GMP, and FDA inspections.