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Fall 2021
5297 FDA Law - ARMSTRONG- 27791

Professor(s): Mark Armstrong (ADJUNCT)

Credits: 2

Course Areas: Health Law 

Time: 4:00p-6:00p  W  Location: 213  BLB

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

Course Notes:   Whether this course will be distance education, or will have a physical room assigned, and if so the extent to which the instructor might use the room during the semester, is not determined at the time when registration initially opens for this course.  You may see contrary indications in the UH systems where you actually register for the course.  In other words, this course might be distance education with no use of a physical classroom. It might be the “HyFlex” mode in which some Law Center courses used a physical room during 2020-21. As we get closer to the start of the term/semester for this course, this course note will be updated as decisions are determined. The instructors will be involved in those decisions, but decisions about modalities may not be invariant throughout the term/semester or between now and when the course starts.

Quota=15.

Professor Armstrong's bio is listed below:
Bio

Prerequisites:  

First Day Assignments:

Final Exam Schedule: Paper      

This course will have:
Exam:
Paper:


Satisfies Senior Upper Level Writing Requirement: No

Experiential Course Type: No

Bar Course: No

DistanceEd ABA 306:

Pass-Fail Student Election: Unavailable (Instructor Preference)

Course Materials (6/8/2021 3:26:00 PM)

Book(s) Required

ISBN: 978-1609301750
Food & Drug Law, 4th ed. Hutt, Merrill & Grossman