Nanotechnology can be used in a broad array of FDA-regulated products and is used to develop products in which nanomaterials serve a variety of functions, for example as active ingredients, carriers loaded with an active ingredient, or inactive ingredients. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This presentation will highlight the regulatory considerations for the development and review of drug products containing nanomaterials. These regulatory considerations include the use of advanced analytical methods for adequate characterization of the nanomaterial, in context of its intended use and function in the drug product. We will also explore the risk based-framework for development and regulatory review of drug products containing nanomaterials, in the recently published Draft Guidance For Industry: Drug Products, Including Biological Products, that Contain Nanomaterials. Lastly, we will discuss the contribution of regulatory research to the advancement of nanotechnology in drug products by furthering FDA’s understanding of the physicochemical properties of nanomaterials and their role in drug product quality, safety and efficacy.

Regulatory science and considerations for drug products containing nanomaterials: FDA perspective

256th National Meeting (2018)

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