Mar 28, 2024  
2021/2022 University Catalog 
    
2021/2022 University Catalog [ARCHIVED CATALOG]

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.