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FDA Issues Draft Guidance on Nanomaterial Drug Development

Dec. 20, 2017

The FDA released a draft guidance for the development of drugs that use nanomaterials, stating the importance of describing and analyzing nanomaterials and their attributes in a product’s finished form.

The guidance suggests drugmakers include a description of the nanomaterials in the product, covering size, charge, composition, complexation and morphology, in order to ensure consistent quality. The agency suggested that functionality be included as well.

Only nanomaterial properties that could affect a product’s performance, safety or quality should be defined, alongside potential risks posed from any changes. A nanomaterial of a different size or shape could be seen as a batch consistency issue if it affects the quality, efficacy or safety of the product.

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