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

September 27-28, 2010
Boston, MA

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

Meet the Speakers

Daniel A. Kracov
Arnold & Porter