FDA is announcing the availability for public comment a draft guidance on Drug Products, Including Biological Products, that Contain Nanomaterials.
Nanotechnology allows scientists to create, explore and manipulate materials on a scale measured in nanometers—particles so small that they cannot be seen with a regular microscope. Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products.
The draft guidance provides recommendations to industry engaged in developing human drug products in which a nanomaterial is present in the finished dosage form, including recommendations regarding investigational, premarket, and postmarket submissions for these products.
Nanomaterials in drug products may perform a variety of functions, for example, as active ingredients, carriers loaded with an active ingredient, or inactive ingredients. This draft guidance describes a risk-based approach to the regulation of these products, focusing on the characteristics of the nanomaterial, its intended use and application, and evaluating how its attributes may relate to product quality, safety, and efficacy.
We are seeking comment on the draft guidance including on the terminology used in the document. The docket opens for public comment on Monday, December 18, 2017. To comment on the draft guidance, please go to http://www.regulations.gov and insert docket number: FDA-2017-27133.