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- Introduction and overview
- How does the FDA think about nanomedical systems?
- The 2006 Nanotechnology Task Force
- Some details of the Nanotechnology Task Force Report
- General findings of the report
- Some initial recommendations of the Task Force
- Where the FDA may need to meet EPA on nanoscale materials
- Will FDA re-visit GRAS products containing nanomaterials?
- How will the FDA consider nanomedical systems?
- Nanomedical systems are integrated nanoscale drug and drug delivery devices
- Either a drug or a device? How about a "Combination Product"?
- Drug-Biologic combination products
- EPA and other regulatory agency issues
- Assessing environmental impact of emerging nanotechnologies
- Concept of life cycle assessment (LCA)
- Toxicity of nanomaterials
- Some recommendations of the 2006 International Conference on Nanotechnology and Life Cycle Assessment
- Nanotechnologies and the workplace
- NIOSH – Formulating workplace safety standards for nanotechnology
- Protecting workers in the workplace
- Assessing hazards in the workplace
- Establishing a Nanotechnology Safety System
- 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," https://nanohub.org/resources/3549.
Biomedical Engineering Building, Room 1083