BME 695N Lecture 21: FDA and EPA Regulatory Issues

By James Leary

Basic Medical Sciences and Biomedical Engineering, Purdue University, West Lafayette, IN

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  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
    5. 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


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Researchers should cite this work as follows:

  • James Leary (2007), "BME 695N Lecture 21: FDA and EPA Regulatory Issues,"

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