BME 695N Lecture 21: FDA and EPA Regulatory Issues

Outline: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 productsEPA 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 AssessmentNanotechnologies and the workplace NIOSH – Formulating workplace safety standards for nanotechnology Protecting workers in the workplace Assessing hazards in the workplace Establishing a Nanotechnology Safety SystemThe future of nano-healthcare products