ABMS 5313. Medical Product Development & FDA Regulations. 3 Hours.
Students examine regulatory processes for the development and approval of medical products with an emphasis on U.S. Food and Drug Administration (FDA) requirements. Topics may include pre-clinical studies, Investigational New Drug (IND) applications, clinical trial phases, and New Drug Application (NDA) or Premarket Approval (PMA) submissions. Students analyze FDA oversight of labeling, post-market surveillance, and adverse event reporting. Students investigate regulatory pathways for medical devices, drugs, biologics, and combination products, and evaluate common challenges companies encounter in achieving compliance.
Prerequisite: ABMS 5301, ABMS 5302, ABMS 5303 & ABMS 5304.
