The AAPS Journal

, Volume 15, Issue 3, pp 623–628

CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

  • Celia N. Cruz
  • Katherine M. Tyner
  • Lydia Velazquez
  • Kenneth C. Hyams
  • Abigail Jacobs
  • Arthur B. Shaw
  • Wenlei Jiang
  • Robert Lionberger
  • Peter Hinderling
  • Yoon Kong
  • Paul C. Brown
  • Tapash Ghosh
  • Caroline Strasinger
  • Sandra Suarez-Sharp
  • Don Henry
  • Maat Van Uitert
  • Nakissa Sadrieh
  • Elaine Morefield
Regulatory Note Theme: Nanotechnology in Drug Development

DOI: 10.1208/s12248-013-9466-6

Cite this article as:
Cruz, C.N., Tyner, K.M., Velazquez, L. et al. AAPS J (2013) 15: 623. doi:10.1208/s12248-013-9466-6

Abstract

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration was established to assess the possible impact of nanotechnology on drug products. The group is in the process of performing risk assessment and management exercises. The task of the working group is to identify areas where CDER may need to optimize its review practices and to develop standards to ensure review consistency for drug applications that may involve the application of nanotechnology. The working group already performed risk management exercises evaluating the potential risks from administering nanomaterial active pharmaceutical ingredients (API) or nanomaterial excipients by various routes of administration. This publication outlines the risk assessment and management process used by the working group, using nanomaterial API by the oral route of administration as an example.

KEY WORDS

CDERnanomaterialnanotechnologyrisk assessmentrisk management

Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  • Celia N. Cruz
    • 1
  • Katherine M. Tyner
    • 1
  • Lydia Velazquez
    • 1
  • Kenneth C. Hyams
    • 1
  • Abigail Jacobs
    • 1
  • Arthur B. Shaw
    • 1
  • Wenlei Jiang
    • 1
  • Robert Lionberger
    • 1
  • Peter Hinderling
    • 1
  • Yoon Kong
    • 1
  • Paul C. Brown
    • 1
  • Tapash Ghosh
    • 1
  • Caroline Strasinger
    • 1
  • Sandra Suarez-Sharp
    • 1
  • Don Henry
    • 1
  • Maat Van Uitert
    • 1
  • Nakissa Sadrieh
    • 1
  • Elaine Morefield
    • 1
  1. 1.Center for Drug Evaluation and ResearchUnited States Food and Drug AdministrationSilver SpringUSA