ADHA7065 · Advancing Studies
ADV
This course will provide an overview of the U.S. Food and Drug Administration (FDA), explore the history of laws related to medical product development, commercialization, and clinical use, and will consider relevant cases whose decisions have been important in establishing precedents and current guidelines. Governing medical products are the beginning point for regulations that identify how research, development and marketing should be pursued. Reviewing and analyzing the development to commercialization will follow the investigational device exemptions (IDE), premarket approval, 510(k) application process, and product development protocols and review processes.
Course experience
Averages use the original five-point historical evaluation scale.
Organization
4.7 / 5
How well the course was organized
Challenge
4.7 / 5
How intellectually challenging students found it
Attendance
3.3 / 5
How necessary attendance was
Assignments
4.7 / 5
How helpful assignments were
Weekly effort
~9
hours per week
Estimated from the original workload response buckets. Individual sections may differ.
Instructor options
Ratings below reflect the evaluations connected to this course.
Across time
Available section-level results across semesters.
Spring 2025
1 section2024FALL1
1 sectionSpring 2024
1 section