LSTU 6604 Legal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices 3.0 Credits
This course surveys the legal and regulatory framework governing pharmaceutical and medical device companies in highly regulated markets. Students examine product development from pre-clinical research through clinical trials and NDA approval, while learning to analyze issues using the IRAC method. The course emphasizes advertising and communications, including FTC jurisdiction, risk disclosure, off-label promotion, social media, constitutional limits on regulation, and interactions with healthcare professionals. Practical assignments focus on identifying compliance risk and advising regulated businesses.
Repeat Status: Not repeatable for credit