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Fall 2023

5237 FDA Law - ARMSTRONG- 24864

Professor(s): Mark Armstrong (ADJUNCT)

Credits: 2

Course Areas: Health Law 

Time: 4:00p-6:00p  W  Location: 312 

Course Outline: Pharmaceutical products and medical devices account for a significant portion of healthcare services, so a basic understanding of FDA/Pharmacy law is essential for any student wishing to work in, or to represent clients in the healthcare sector. This course provides a manageable introductory survey of the major substantive topics in FDA Law, particularly relating to drugs, biologics, biosimilars, and medical devices and the interaction of state pharmacy laws relating to dispensing and distribution of those products. After providing a basic tour of FDA law and applicable state pharmacy laws, the course will turn to discussion of hot topics in FDA/Pharmacy laws, which students will select in consultation with Professor Armstrong.

Course Syllabus: Syllabus Updated 08/07/2023

Course Notes: (Face-to-Face)  The UH registration system instruction mode for this course is listed in parenthesis. After student registration opens, there may be instruction mode changes to this course up through two weeks before the first day of classes for the term, but notice of such changes will be sent to then-registered students. For this instruction mode, instructors and students are expected to normally be physically present in the classroom. If the course has a final examination, it will be in a classroom requiring your physical presence. Other assessment, such as a mid-term exam, may also be in a classroom. Whether this instructor will offer “remote presence” (starting a zoom meeting from the podium computer to enable student remote access on an occasional basis) for part or all of the semester is not known, but students should not rely on an expectation that remote presence will be available.


Professor Armstrong's bio is listed below:


First Day Assignments:

Final Exam Schedule: 12/6 4-6pm      

This course will have:

Satisfies Senior Upper Level Writing Requirement: No

Experiential Course Type: No

Bar Course: No

DistanceEd ABA: No

Pass-Fail Student Election: Unavailable (Instructor Preference)

Course Materials

Book(s) Required

ISBN: 978 1636596952
See full book details on syllabus