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

R A 774: Investigational and Marketing Applications for Drugs and Biologics (3 units) at San Diego State University. Not offered in Spring 2027. Prerequisites: R A 602. Counts toward Regulatory Affairs, M.S. (2026-27), Regulatory Affairs, M.S. (2025-26).

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3 units
  • Required Courses
  • Electives
Offered: Summer 2027 (not offered), Spring 2027 (unknown), Fall 2026 (offered)

Counts toward

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.
Prerequisites
R A 602
See the full prerequisite chain

From the catalog

Grading
LTR: Letter Graded. The class will be offered for letter grade with no option to take it for Cr/NC
Repeatable
3 Maximum Credit Statement: combined credit six units of R A 773 and R A 774 applicable to a master’s degree

0 sections in Spring 2027

R A 774 is not offered in Spring 2027. Check all R A classes for other terms.