A new document from the U.S. Food and Drug Administration (FDA):
Nanotechnology can be used in a broad array of FDA-regulated products, such as human Drug Products, including those that are biological products. Nanotechnology may be used to create drug products in which nanomaterials serve a variety of functions, for example as active ingredients, carriers loaded with an active ingredient, The inclusion of such materials or inactive ingredients may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form.
FDA’s consideration of the use of nanomaterials in drug products, including those that are biological products, in this document is consistent with FDA’s nanotechnology considerations guidance, and with the broader federal guidance on regulatory oversight of emerging technologies and nanotechnology.
Posted by Dr. Tim Sandle