BIOT 214 - Food and Drug Law

1. Understanding of the Food and Drug Administration (FDA), including:
   • How drug and medical device regulation can be understood in the larger context of the U.S. legal system
   • The history of regulations: how the development and regulatory processes evolved
   • FDA organizations and functions
   • Review of FDA inspections and related regulations
   • Laws and regulations governing combination products
   • The newly passed Food and Drug Administration Amendments Act of 2007 (FDAA Act), and how it impacts the pharmaceutical, biotechnology and medical device industries.
2. Understanding of the drug/biologics and medical device approval process and applicable regulations.
3. 3 Ability to locate information students might need in their role as regulatory affairs professionals.
4. Understanding of pharmacovigilance and various reporting compliance.
5. Understanding of international laws and regulations including:
   • The legal framework in the European Union
   • Laws and Agencies in Canada
   • Laws and Agencies in Japan
   • Laws and Agencies in Australia
   • International initiatives
6. Appreciation of the subjective and interpretive aspects of regulations, and ability to think critically about the interaction between regulatory agencies.
7. Understanding application of the drug, biological and medical device approval process.
8. Understanding of pharmacovigilance and various reporting regulations, guidance and Risk Maps.

• Regulatory agencies and compliance (FDA, TGA, MHLW, Health Canada, EU)
• Current Good Clinical Practices (cGCP)
• Standard Operating Procedures (SOP)
• CFR Title 21
• Federal Food Drug and Cosmetic Act (FDCA)
• MedWatch
• Annual reporting and regulatory compliance

 
GRADING POLICY

 
Course Addendum - Syllabus (Click to expand)