Fundamentals of FDA Regulation

Catalog description

This introductory course provides an overview of Regulatory Affairs in relation to three key areas of development: Drugs, Medical Devices, and Biologics including gene therapy and vaccines. Students will gain insight into the pivotal role of FDA in regulating medical products, as well as explore the therapeutic product development life cycle process from initial concept to market entry. Special emphasis will be placed on formulating regulatory strategies including determining pre-clinical and clinical testing requirements for the three key areas in support of clinical trials and commercialization. Furthermore, the course will dissect different types of FDA enforcement actions and equip students with knowledge to navigate pre- and post- approval compliance challenges effectively. Practical issues encountered by regulatory specialists in collaboration with the FDA will be addressed. Real-world case studies and interactive discussions will provide students with valuable insights into overcoming regulatory hurdles and securing product approvals in a competitive domestic market.