Executive Summary
Introduction
Task Force Mission
Definitions for Nanotechnology and Related Terms
Organization of this Report
State of the Science of Nanotechnology Relevant to FDA
Science Issues
Introduction
Issue: Understanding Interactions of Nanoscale Materials with Biological Systems
Issue: Adequacy of Testing Approaches for Assessing Safety and Quality of Products Containing Nanoscale Materials
Regulatory Policy Issues
Background
Discussion
Issue: Ability of FDA to Identify FDA-Regulated Products that Contain Nanoscale Materials
Issue: Scope of FDA's Authority Regarding Evaluation of Safety and Effectiveness
Issue: Permissible and Mandatory Labeling
Issue: National Environmental Policy Act
Introduction
Task Force Mission
Definitions for Nanotechnology and Related Terms
Organization of this Report
State of the Science of Nanotechnology Relevant to FDA
Science Issues
Introduction
Issue: Understanding Interactions of Nanoscale Materials with Biological Systems
Issue: Adequacy of Testing Approaches for Assessing Safety and Quality of Products Containing Nanoscale Materials
Regulatory Policy Issues
Background
Discussion
Issue: Ability of FDA to Identify FDA-Regulated Products that Contain Nanoscale Materials
Issue: Scope of FDA's Authority Regarding Evaluation of Safety and Effectiveness
Issue: Permissible and Mandatory Labeling
Issue: National Environmental Policy Act