N Sadrieh and T J Miller

8.1 Introduction 139

8.2 FDA Experience with Nanotechnology Product Applications 140

8.3 FDA Definition of Nanotechnology 143

8.4 FDA Initiatives in Nanotechnology 143

8.5 Research at the FDA on Nanotechnology 145

8.6 Regulatory Considerations for Nanotechnology Products 145

8.6.1 Jurisdiction of Nanotechnology Products 145

8.6.2 Existing FDA Regulations That Apply to Nanomaterial-Containing Products 146

8.7 Scientific Considerations for the Development of Nanotechnology Products 147

8.7.1 Characterization of Nanoparticles 147

8.7.2 Safety Considerations 149

8.8 Conclusions 149

8.9 Trademark Listing 151

References 151

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