BME 695L Lecture 16: FDA and EPA Regulatory Issues

By James Leary

Biomedical Engineering, Purdue University, West Lafayette, IN

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See references below for related reading.

16.1      Introduction and overview
16.1.1    How does the FDA think about nanomedical systems?
16.1.2    The 2006 Nanotechnology Task Force

16.2      Some details of the Nanotechnology Task Force Report
16.2.1    General findings of the report
16.2.2    Some initial recommendations of the Task Force
16.2.3    Where the FDA may need to meet EPA on nanoscale materials
16.2.4    Will FDA re-visit GRAS products containing nanomaterials?

16.3      How will the FDA consider nanomedical systems?
16.3.1    Nanomedical systems are integrated nanoscale drug and drug delivery devices
16.3.2    Either a drug or a device? How about a "Combination Product"?
16.3.3    Drug-Biologic combination products

16.4      Types of human clinical trials
16.4.1    IND
16.4.2    “Phase 0”
16.4.3    Phase 1
16.4.4    Phase 2
16.4.5    Phase 3
16.4.6    Phase 4

16.5      EPA and other regulatory agency issues
16.5.1    Assessing environmental impact of emerging nanotechnologies
16.5.2    Concept of life cycle assessment (LCA)
16.5.3    Toxicity of nanomaterials
16.5.4    Some recommendations of the 2006 International Conference on Nanotechnology and Life Cycle Assessment

16.6      Nanotechnologies and the workplace
16.6.1    NIOSH – Formulating workplace safety standards for nanotechnology
16.6.2    Protecting workers in the workplace
16.6.3    Assessing hazards in the workplace
16.6.4    Establishing a Nanotechnology Safety System

16.7      The future of nano-healthcare products


Copyright © 2011, James F. Leary, All rights reserved.


Commissioner of Food and Drugs "Nanotechnology Task Force Report 2007" July 25, 2007
"Environmental impact of nanotechnology documents: Life Cycle Assessments"
NIOSH Nanotechnology Research Center "Progress Toward Safe Nanotechnology in the Workplace"
Nano Healthcare Products Assessment. The Freedonia Group, Inc
Chinese FDA

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  • James Leary (2011), "BME 695L Lecture 16: FDA and EPA Regulatory Issues,"

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