BME 695L Lecture 16: FDA and EPA Regulatory Issues

See references below for related reading.16.1 Introduction and overview16.1.1 How does the FDA think about nanomedical systems?16.1.2 The 2006 Nanotechnology Task Force16.2 Some details of the Nanotechnology Task Force Report16.2.1 General findings of the report16.2.2 Some initial recommendations of the Task Force16.2.3 Where the FDA may need to meet EPA on nanoscale materials16.2.4 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 devices16.3.2 Either a drug or a device? How about a "Combination Product"?16.3.3 Drug-Biologic combination products16.4 Types of human clinical trials16.4.1 IND16.4.2 “Phase 0”16.4.3 Phase 116.4.4 Phase 216.4.5 Phase 316.4.6 Phase 416.5 EPA and other regulatory agency issues16.5.1 Assessing environmental impact of emerging nanotechnologies16.5.2 Concept of life cycle assessment (LCA)16.5.3 Toxicity of nanomaterials16.5.4 Some recommendations of the 2006 International Conference on Nanotechnology and Life Cycle Assessment16.6 Nanotechnologies and the workplace16.6.1 NIOSH – Formulating workplace safety standards for nanotechnology16.6.2 Protecting workers in the workplace16.6.3 Assessing hazards in the workplace16.6.4 Establishing a Nanotechnology Safety System16.7 The future of nano-healthcare products