Course Description
Overview of laws and regulations governing the development, manufacturing, and commercial distribution of drugs, biologic, and medical device products and how they relate to the pharmaceutical, biotechnology, and medical device industries. This course focuses on domestic regulatory requirements of the Food and Drug Administration and its jurisdiction.
Athena Title
Food and Drug Law
Equivalent Courses
Not open to students with credit in PHAR 6020
Non-Traditional Format
This course is taught 95% or more online. Four hours per week for fifteen weeks of online study, including teaching, assignments, discussion, problem-based learning, and case-based learning. Weekend seminar(s) totaling eight contact hours (onsite or web, video conference) utilizing case-based and problem-based learning methods.
Prerequisite
PHAR 6010 or PHAR 6010E or permission of department
Grading System
A - F (Traditional)
Course Objectives
1) Describe federal regulation of pharmaceuticals, biologics, medical devices, combination products, and animal health product-related laws, regulations, and guidelines; 2) Explain how the FDA enforces the law and regulations; 3) Identify legal issues surrounding product liability, import/export, and post-marketing surveillance obligations; 4) Locate reference information used in the role of regulatory affairs professional, including FDA guidance documents; 5) Interpret FDA laws and regulations and write persuasively about the interpretation; 6) Understand the history of key regulations, including the development and evolution of the FDA regulatory process; 7) Describe the subjective and interpretative aspects of regulations.
Topical Outline
Overview of regulatory requirements (AIP, ELA, PLA, DMF, NDA, INDA, ANDA, IDE, PMA, 510(k)) Overview of the FDA and its jurisdiction, including its administrative centers, CBER, CDER, CFSAN, CDRH, CVM The U.S. 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 FDA enforcement Product liability, import/export requirements, orphan products, humanitarian, and combination products
Syllabus
Public CV