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Nanotechnology and the FDA: What Are the Scientific and Regulatory
Considerations for Products Containing Nanomaterials?
Volume 3, Issue 3
Authors:
Nakissa Sadrieh, FDA
Parvaneh Espandiari, FDA
Abstract:
While certain types of nanotechnology applications have already been used in marketed products, it appears that the future holds many more opportunities for diverse applications of nanotechnology in products that will be regulated by the Food and Drug Administration (“FDA”). To this end, the FDA has taken several steps to prepare for the arrival of these novel applications of nanotechnology. In this article, Nakissa Sadrieh and Parvaneh Espandiari identify some of the steps taken by the FDA to meet the challenges of nanotechnology applications in drug and drug delivery systems. Specifically, some of the scientific considerations that have been voiced specifically within Center for Drug Evaluation and Research (“CDER”) will be identified in this paper.
Full Text (PDF)
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