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Spring 2020
5297 FDA Law - ARMSTRONG- 24884

Professor(s): Mark Armstrong (ADJUNCT)

Credits: 2

Course Areas: Health Law 

Time: 5:30p-7:30p  TH  Location: 215  TUII

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:   Quota=15.

Professor Armstrong's bio is listed below:
Bio

Prerequisites:  

First Day Assignments:

Final Exam Schedule: Exam/Paper      

This course will have:
Exam:
Paper:

Satisfies Skills Course Requirement: No
Satisfies Senior Upper Level Writing Requirement: No

Experiential Course Type: No

Bar Course: No

DistanceEd ABA 306:

Pass-Fail Student Election:

Course Materials (11/20/2019 11:54:38 AM)

Special Case

a. Food and Drug Administration, 4th, 2019-1 ed. Access via Westlaw subscription at https://www.westlaw.com/Browse/Home/SecondarySources/HealthLawSecondarySources/HealthLawTextsTreatises/FoodDrugAdministrationFourthEdition?transitionType=Default&contextData(sc.Default)&VR=3.0&RS=cblt1.0

b. Statute (FDCA/21 U.S.C.) -- Access via FDA website, at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm

c. Regulations (21 C.F.R.) -- Access via FDA website, at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

d. Texas Pharmacy Act (Tex. Occ. Code §§551 – 569) – Access via https://www.pharmacy.texas.gov/Rules_Pharmacy_Act.asp

e. Texas Pharmacy Rules (22 TAC §§281 - 385) – Access via https://www.pharmacy.texas.gov/Rules_Pharmacy_Rules.asp