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