1. Introduction and overview
1. How does the FDA think about nanomedical systems?
2. The 2006 Nanotechnology Task Force
2. Some details of the Nanotechnology Task Force Report
1. General findings of the report
2. Some initial recommendations of the Task Force
3. Where the FDA may need to meet EPA on nanoscale materials
4. Will FDA re-visit GRAS products containing nanomaterials?
3. How will the FDA consider nanomedical systems?
1. Nanomedical systems are integrated nanoscale drug and drug delivery devices
2. Either a drug or a device? How about a "Combination Product"?
3. Drug-Biologic combination products
4. EPA and other regulatory agency issues
1. Assessing environmental impact of emerging nanotechnologies
2. Concept of life cycle assessment (LCA)
3. Toxicity of nanomaterials
4. Some recommendations of the 2006 International
Conference on Nanotechnology and Life Cycle Assessment
5. Nanotechnologies and the workplace
1. NIOSH – Formulating workplace safety standards for nanotechnology
2. Protecting workers in the workplace
3. Assessing hazards in the workplace
4. Establishing a Nanotechnology Safety System
6. The future of nano-healthcare products

• Nanotechnology A Report of the U.S. Food and Drug Administration Nanotechnology Task Force July 25, 2007 at http://www.fda.gov/nanotechnology/taskforce/report2007.pdf
• Environmental impact of nanotechnology documents: Life Cycle Assessments - http://www.nanotechproject.org/111/32007-life-cycle-assessment-essential-to-nanotech-commercial-development
• NIOSH workplace documents: http://www.cdc.gov/niosh/docs/2007-123/pdfs/2007-123.pdf
• Nano Healthcare Products assessment: The Freedonia Group, Inc.

Researchers should cite this work as follows:

• James Leary (2007), "BME 695N Lecture 21: FDA and EPA Regulatory Issues," http://nanohub.org/resources/3549.

1. biomedical engineering 1
2. course lecture 1
3. nanomedicine 1
4. risk assessment 1
5. toxicology 1