crb804: Biotechnology Regulation and Ethics
Year 1, Fall Semester (2 credits)
Saturday mornings, 8:00am – 12:00pm (every other week)
Irving Shain Conference Room, MGE Innovation Center
University Research Park
Since biotechnology emerged as an industry, political and ethical legal issues have shaped its development.
This course will expose you to some of the most important areas of regulation, including FDA oversight of gene therapy and drug, device and biologics development; EPA/USDA regulation of agricultural applications of biotechnology; federal regulation of genetic testing services; and the politics and regulation of embryonic stem cell research.
You’ll learn how regulation is developed and how it interacts with business and finance to influence the formation and growth of biotechnology companies.
You’ll also explore the ethical issues that help shape public policies on biotechnology and its applications.
Session Topics from Fall 2021
Session 1: Introduction to the US Legal System; Introduction to the U.S. FDA
Session 2: FDA Regulation of Biotechnology I â€“ Drugs
Session 3: FDA Regulation of Biotechnology II â€” Biologics and Devices
Session 4: Drug Marketing and the First Amendment;
Ethics and Regulation of Research With Human Participants
Session 5: Regulation of Industrial Chemical Production Using Biotechnology: EPA, FDA, and USDA
Session 6: Regulation and ethics of genomic and other omic testing; Ethics of Gene Editing in Humans
Session 7: Discussion of Student Papers on US Senate Bill S. 204, “Right to Try Act of 2017”