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The evolving landscape of drug products containing nanomaterials in the United States

Nature Nanotechnology volume 12, pages 523–529 (2017)Cite this article

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Abstract

The Center for Drug Evaluation and Research (CDER) within the US Food and Drug Administration (FDA) is tracking the use of nanotechnology in drug products by building and interrogating a technical profile of products containing nanomaterials submitted to CDER. In this Analysis, data from more than 350 products show an increase in the submissions of drug products containing nanomaterials over the last two decades. Of these, 65% are investigational new drugs, 17% are new drug applications and 18% are abbreviated new drug applications, with the largest class of products being liposomal formulations intended for cancer treatments. Approximately 80% of products have average particle sizes of 300 nm or lower. This analysis identifies several trends in the development of drug products containing nanomaterials, including the relative rate of approvals of these products, and provides a comprehensive overview on the landscape of nanotechnology application in medicine.

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Figure 1: Number of nanomaterial product applications submitted to CDER by year.
Figure 2: CDER approved drug products containing nanomaterials by year.
Figure 3: Distribution of nanomaterial use in drug products from 1973 to 2015.
Figure 4
Figure 5: Particle sizes within drug products containing nanomaterials from 1973 to 2015.

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Acknowledgements

This project was supported in part by an appointment to the Research Participation Program at the Center for Drug Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the US Department of Energy and the US Food and Drug Administration. The findings and conclusions in this Analysis 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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  1. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, 20993, Maryland, USA

    Sheetal R. D'Mello, Celia N. Cruz, Mei-Ling Chen, Mamta Kapoor, Sau L. Lee & Katherine M. Tyner

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  1. Sheetal R. D'Mello
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  2. Celia N. Cruz
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Contributions

K.M.T., C.N.C. and S.L.L. conceived and designed the project. S.R.D., M.K. and M.-L.C. conducted the analysis. K.M.T. and S.R.D. co-wrote the paper. All authors discussed the results and commented on the manuscript.

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Correspondence to Katherine M. Tyner.

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D'Mello, S., Cruz, C., Chen, ML. et al. The evolving landscape of drug products containing nanomaterials in the United States. Nature Nanotech 12, 523–529 (2017). https://doi.org/10.1038/nnano.2017.67

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