FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers

The Basics: Understanding and Working with the FDA - Jurisdiction, Functions, Organization, and Operations

• FDA Overview
• How the FDA is organized
  • Department of Health and Human Services and the Commissioner
  • The 5 FDA Centers and the Office of Regulatory Affairs and their functions
• The 3 major centers and their roles
  • CDER (Drug)
  • CBER (Biologic)
  • CDRH (Device)
• Understanding how CDER and CBER intersect
  • intersection with CDRH
• Defining the scope of the FDA's jurisdiction
• Examining how the FDA exercises its jurisdiction:
  • rule making
  • product decisions
  • enforcement
  • informal mechanisms
• Reviewing the laws that the FDA enforces
• Defining drugs, biologics, and medical devices
• Emerging and expanding technologies
  • cell and tissue-based products
  • nanotechnology
• Labeling: when is a drug a drug and not a medical device or cosmetic, and the consequences
• Defining combination products
• Working with the FDA
  • Administrative Procedures Act
  • formal and informal dispute resolution mechanisms
• FDA's policies and procedures