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April 28, 2017

CDER Officials: Nanomaterial Submissions on the Rise

  • Agency
  • Nanotechnology

Regulatory Affairs Professionals Society – A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise.

The finding stems from an analysis published Monday in Nature Nanotechnology, in which the officials look at trends in submissions involving nanomaterials over the last 40 years.

In the analysis, the authors say the number of investigational new drug applications (INDs), new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for products containing nanomaterials has increased steadily, from a trickle in the 1970s and early '80s to 20 or more per year for much of the last decade.

Read more at Regulatory Affairs Professionals Society.

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