BIOT 214 - Food & Drug Law

or Program Advisor Approval.

PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Fall 2022

This course provides a basic introduction to the laws and regulations that govern the development, marketing and commercial distribution of drugs, biological and medical device products and how they relate to the pharmaceutical, biotechnology and medical devices industry. This course is designed to provide students with an overall landscape of U.S. laws regulating the drug, biotechnology and medical device industry.

MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to:

1. Understand the roles of the Executive, Legislative, and Judiciary branches of the U.S. government with respect to Food and Drug Law.
2. Understand the history of the FDA’s development from pre-1906 to present.
3. Understand the FDA organizational structure and the functions of selected FDA centers/offices.
4. Find FDA-related laws in the U.S. Code (USC).
5. Understand the difference between U.S. laws (statues) recorded in the USC and regulations from executive agencies recorded in the Code of Federal Regulations (CFR).
6. Use the FDA.gov website to find information about bringing a drug or medical device to market.
7. Understand how to use and apply FDA PDUFA and FDA Meeting guidance documents.  
8. Understand the FDA new drug application (NDA) process.
9. Understand the FDA Medical Device Approval and development process. 
10. Read and apply portions of Title 21 Part 807 to showing substantial equivalent (SE).  
11. Read and apply appropriate standards and guidance documents in demonstrating substantial equivalent (SE).
12. Read the FDA drug approval case study and the provided guidance documents, and use these resources to research competitor drugs (empagliflozin, dapagliflozin, and canagliflozin).
13. Read an FDA Medical device approval case study and apply appropriate database search skills. 
14. Understand how to use and apply ICH M3 (R2), S3A, and S7A guidance documents.
15. Read and apply appropriate standards and guidance documents, including items from ISO 14155 and ISO 14971, to demonstrating RA development processes in the Premarket Approval pathway.

• Regulatory agencies and compliance (FDA)
• Current Good Clinical Practices (cGCP)
• Standard Operating Procedures (SOP)
• CFR Title 21
• Federal Food Drug and Cosmetic Act (FDCA)
• Searchable FDA.gov Databases
• Standards and their role in the regulatory environment.
• Utility of ISO 14971 and ISO 14155