This course explores the FDA’s extensive regulation of the pharmaceutical and medical device industries, as well the relationship between FDA regulation and state-law tort liability. Topics covered include the FDA approval process, pharmacovigilance, products liability and FDA preemption, FDA oversight of advertising and promotion, and life science companies and the First Amendment.
Upon completion of this course, you will be able to:
- Recognize key sources of law applicable to drug and device approval and marketing and explain what companies must do to comply with these requirements
- Analyze real-world situations related to drug and device approval and marketing in order to spot legal issues and formulate options
- Develop strategies for avoiding legal problems by designing policies and practices in light of legal requirements
- Use Internet-based research tools to find authoritative statements of the law and answers to legal questions
- Evaluate proposed changes in the law related to drug and device approval and marketing and assess their implications for the pharmaceutical and medical device industries
- Recognize situations in which professional legal advice is necessary and communicate effectively with legal counsel
The FDA Regulation and Liability course can be completed in just 8 weeks. Coursework must be completed in the sequence in which it is offered. You should plan to spend about 6-8 hours per week on online coursework, including reading assignments, research and writing projects, and online discussions.