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Food and Drug Law

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 6020E

Non-Traditional 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 PHAR 6010E or permission of department

Grading System

A - F (Traditional)

Student learning Outcomes

  • 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))
  • Overview of regulatory agencies and their jurisdiction (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
  • FNA enforcement
  • Product liability, import/export requirements, orphan products, humanitarian, and combination products
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