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Mar 28, 2024
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2021/2022 University Catalog [ARCHIVED CATALOG]
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R A 772 - Post-Approval Activities Units: 3
Prerequisite(s): R A 602 .
FDA and FTC rules and regulations governing advertising, labeling, and promotion for biologics, generic, over-the-counter, and prescription drugs; and medical devices. Annual reporting requirements, changes to approved marketing applications, Good Manufacturing Practice inspections, post-marketing adverse reaction reporting, product recalls, and risk management.
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