| Course ID: | PHAR 6020E. 3 hours. |
| Course Title: | Food and Drug Law |
Course
Description: | Overview of laws and regulations governing development,
manufacturing, and commercial distribution of drugs, biologic
and
medical device products and how they relate to the
pharmaceutical, biotechnology, and medical device industry.
Domestic and international regulatory requirements and various
regulatory agencies and their jurisdiction. |
| Oasis Title: | FOOD AND DRUG LAW |
| Duplicate Credit: | Not open to students with credit in PHAR 6020 |
| Nontraditional Format: | Four hours per week for fifteen weeks online study, including
teaching, assignments, discussion, problem-based learning, and
case-based learning. Weekend seminar(s)totaling sixteen contact
hours (onsite or GSAMS multi-point video conference) utilizing
case-based and problem-based learning methods (equivalent to
three credit hours of recitation format). |
| Prerequisite: | PHAR 6010 or permission of department |
| Grading System: | A-F (Traditional) |
|
| Course Objectives: | Explain food-drug and cosmetic-related laws, regulations and
guidelines; explain how the FDA enforces the law and
regulations; identify legal issues surrounding product
liability, import/export, and post marketing surveillance
obligations. Locate and reference information used in the role
of regulatory affairs professional; interpret FDA laws and
regulations and write persuasively about the interpretation. |
| Topical Outline: | Overview of regulatory requirements (AIP, ELA, PLA, DMF, NDA,
INDA, ANDA , IDE, PMA, 510(k) etc); Overview of regulatory
agencies and their jurisdiction (CBER, CDER, CFSAN, CDRH, CVM;
The US legal system; the Food, Drug and Cosmetic Act and its
related laws; the Freedom of Information Act; regulations
affecting foods, cosmetics, drugs, biologics, veterinary
products, devices and diagnostics; FNA enforcement; product
liability, import/export requirements, orphan products,
humanitarian and combination products. |
| Honor Code Reference: | All academic work must meet the standards contained in A Culture
of Honesty. Each student is responsible to inform themselves
about those standards before performing any academic work. A
Culture of Honesty is the University of Georgia's policy and
procedures for handling cases of suspected dishonesty and can be
found online at www.uga.edu/ovpi. UGA Student Honor Code states
"I will be academically honest in all of my academic work and
will not tolerate academic dishonesty of others." |