LSTU 6605 Food and Drug Law 3.0 Credits
This course provides a high-level survey of the legal and regulatory frameworks governing pharmaceutical and medical device development across the full product lifecycle. Topics include clinical trials and FDA oversight, manufacturing and quality systems, pharmacy compounding, telemedicine, medical device regulation, inspections, generic drugs and biosimilars, fraud and abuse, and cannabis regulation. Through practical, problem-based assignments, students learn to spot regulatory risk, understand compliance obligations, and advise stakeholders operating in highly regulated life sciences markets.
Repeat Status: Not repeatable for credit