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

Nat Nanotechnol. 2017 Jul;12(6):523-529. doi: 10.1038/nnano.2017.67. Epub 2017 Apr 24.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Drug Approval*
  • Drug Design*
  • Humans
  • Liposomes
  • Nanostructures / therapeutic use*
  • Particle Size
  • Pharmaceutical Preparations*
  • United States
  • United States Food and Drug Administration

Substances

  • Liposomes
  • Pharmaceutical Preparations