Mar 29, 2024  
2021/2022 University Catalog 
    
2021/2022 University Catalog [ARCHIVED CATALOG]

R A 774 - Investigational and Marketing Applications for Drugs and Biologics


Units: 3

Prerequisite(s): R A 602 .

Content, planning, requirements, and strategy for developing and preparing Food and Drug Administration regulatory submissions to include biologics license applications (BLA), device premarket applications (PMA), device premarket notifications (510[k]), investigational device exemptions (IDE), investigational new drug applications (IND), new drug applications (NDA). Combination product submissions, future submission trends, and risk management. Maximum Credits: combined credit six units of R A 773  and 774 applicable to a master’s degree.