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# Approvals of Drugs with Nanomaterials Up
- URL: https://www.fdaweb.com/approvals-of-drugs-with-nanomaterials-up/
- Published: 2018-04-27T12:00:00.000Z
- Updated: 2026-09-15T00:01:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141322

CDER Office of Testing and Research senior staff fellow **Xiaoming Xu** says there has been a steady increase in the number of approved drug products containing nanomaterials, including INDs, NDAs, and ANDAs. “More than 60 applications have been approved since the early 1970s and interest continues to rise,” Xu writes in an online *Spotlight on CDER Science* [post](https://www.fda.gov/Drugs/NewsEvents/ucm605837.htm?ref=fdaweb.com).

Xu says that drug products containing nanomaterials are unique in several ways because they may take on different chemical, physical, or biological properties compared to other types of drugs.

For the last decade, he writes, the Office of Testing and Research has been working to better understand the manufacturing and quality issues associated with drug products containing nanomaterials, with the aim of informing agency guidances and regulatory review. The research is addressing challenges associated with developing new drugs using nanotechnology, he says, and is establishing clear standards to pave the way for approval of future generics containing nanomaterials.

A Nanotechnology Risk Assessment Working Group was convened in 2014 to assess the potential impact of nanotechnology on drug products. The working group includes expertise from across FDA and is helping to develop standards for nanomaterials used in drug development and facilitate advancement of the technology. “The working group determined that in most cases, current assessment practices are adequate for evaluating drugs that include nanomaterials, provided the drug applicant conducts studies early in the development process and implements a formulation control strategy to ensure consistent clinical results,” Xu concludes.