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.
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ACKNOWLEDGMENTS
The authors would like to thank the following for their assistance in this exercise: Edward Bashaw, Scott Furness, Narayan Nair, Marie Angeline O’Shea, Arlene Solbeck, Reynold Tan, Douglas Throckmorton, and Helen Winkle.
The findings and conclusions in this article have not been formally disseminated by the USFDA and should not be construed to represent any USFDA 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.
Conflict of Interest
The authors are employed by the US Food and Drug Administration. The authors do not declare any other conflict of interest.
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Guest Editors: Nakissa Sadrieh and Banu Zolnik
The findings and conclusions in this article have not been formally disseminated by the USFDA and should not be construed to represent any USFDA 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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Cruz, C.N., Tyner, K.M., Velazquez, L. et al. CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products. AAPS J 15, 623–628 (2013). https://doi.org/10.1208/s12248-013-9466-6
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DOI: https://doi.org/10.1208/s12248-013-9466-6