Medical Product Development & FDA Regulations.

Catalog description

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 .