41. FDA and Nanotech: Baby Steps Lead to Regulatory Uncertainty

  1. Debasis Bagchi PhD, MACN, CNS, MAIChE4,
  2. Manashi Bagchi PhD, FACN5,
  3. Hiroyoshi Moriyama PhD, FACN6 and
  4. Fereidoon Shahidi PhD, FACS, FAOCS, FCIC, FCIFST, FIAFoST, FIFT, FRSC7
  1. Raj Bawa1,2,3

Published Online: 4 JAN 2013

DOI: 10.1002/9781118451915.ch41

Bio-Nanotechnology: A Revolution in Food, Biomedical and Health Sciences

Bio-Nanotechnology: A Revolution in Food, Biomedical and Health Sciences

How to Cite

Bawa, R. (2013) FDA and Nanotech: Baby Steps Lead to Regulatory Uncertainty, in Bio-Nanotechnology: A Revolution in Food, Biomedical and Health Sciences (eds D. Bagchi, M. Bagchi, H. Moriyama and F. Shahidi), Blackwell Publishing Ltd., Oxford, UK. doi: 10.1002/9781118451915.ch41

Editor Information

  1. 4

    University of Houston College of Pharmacy, Houston, Texas, USA

  2. 5

    NutriToday LLC, Boston, Massachusetts, USA

  3. 6

    Showa Pharmaceutical University, Tokyo, Japan

  4. 7

    Department of Biochemistry, Memorial University of Newfoundland, St. John's, Newfoundland, Canada

Author Information

  1. 1

    Bawa Biotech LLC, Ashburn, VA, USA

  2. 2

    Rensselaer Polytechnic Institute, Troy, NY, USA

  3. 3

    American Society for Nanomedicine, Ashburn, VA, USA

Publication History

  1. Published Online: 4 JAN 2013
  2. Published Print: 18 JAN 2013

Book Series:

  1. Functional Food Science and Technology Series

Book Series Editors:

  1. Fereidoon Shahidi PhD, FACS, FAOCS, FCIC, FCIFST, FIAFoST, FIFT, FRSC

Series Editor Information

  1. Department of Biochemistry, Memorial University of Newfoundland, St. John's, Newfoundland, Canada

ISBN Information

Print ISBN: 9780470670378

Online ISBN: 9781118451915

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Keywords:

  • FDA and nanotech;
  • regulatory uncertainty;
  • FDA and “nanogovernance”;
  • US, FDA regulatory agency;
  • safeguarding public health;
  • FDA-regulated products;
  • nanoproducts, as combination products;
  • selected FDA-approved nanomedicines;
  • EPA, and nanomaterial regulation

Summary

This chapter contains sections titled:

  • Introduction

  • Defining nanotechnology in the context of medicine – Does size matter?

  • FDA confronts nanotech

  • Nanoproducts as combination products?

  • Recommendations, conclusions, and future prospects

  • Statement of disclosure/conflicts of interest

  • References