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How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities

  • Regulatory Note
  • Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future
  • Published:
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Abstract

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group’s major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

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Acknowledgements

Edward Bashaw, Paul C. Brown, Scott Furness, Tapash Ghosh, Don Henry, Peter Hinderling, Kenneth C. Hyams, Abigail Jacobs, Yoon Kong, Robert Lionberger, Elaine Morefield, Narayan Nair, Marie Angeline O’Shea, Nakissa Sadrieh, Arthur B. Shaw, Arlene Solbeck, Caroline Strasinger, Sandra Suarez-Sharp, Reynold Tan, Douglas Throckmorton, Maat Van Uitert, Lydia Velazquez, Keith Webber, and Helen Winkle.

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  1. Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA

    Katherine M. Tyner, Nan Zheng, Stephanie Choi, Xiaoming Xu, Peng Zou, Wenlei Jiang, Changning Guo & Celia N. Cruz

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  1. Katherine M. Tyner
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  2. Nan Zheng
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Correspondence to Celia N. Cruz.

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The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.

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All authors are employed by the US Food and Drug Administration. The authors do not declare any other conflict of interest.

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Tyner, K.M., Zheng, N., Choi, S. et al. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities. AAPS J 19, 1071–1083 (2017). https://doi.org/10.1208/s12248-017-0084-6

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