First Class Assignments for Spring 2018 Semester
Food & Drug Law
Textbook: Adams, Cooper, Hahn & Kahan, Eds., Food and Drug Law and Regulation (FDLI, 3rd ed. 2015). Buy at the Loyola bookstore or order from FDLI directly at heavily discounted student rate. DO NOT buy online from other sources because you will pay the outrageous practitioner price for this book.
- Statute (FDCA/21 U.S.C.__) -- Access via Office of the Law Revision Counsel, U.S. Code, at http://uscode.house.gov/browse.xhtml (Use the title & section search function)
- Regulations (21 C.F.R. __) -- Access via FDA website, at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (Use the title & part search function)
- Additional materials will be posted on Sakai and noted in the syllabus as "Sakai."
(Class 1 Wednesday, January 17: The FDA as a Federal Administrative Agency
Textbook: p. 1-20; 683-686; 710-top 715
Statute: 21 USC §371(a)-(d)(regulations and hearings) & (h)(guidance documents) [Also cited as FDCA §701]
FDA website: Review the FDA Organization Chart: FDA Overview, available at http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm393155.htm
(Class 2 Monday, January 22: FDCA Structure & Definitions
Sakai: Hutt et al, Cases and Materials Supplement S2-S24
Statute: 21 USC 321(f)- (i), (p), (s), (t), (ff), (rr) (various definitions) [Also cited as FDCA §201]