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GUIDANCE DOCUMENT

Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry April 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-0759
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products.3 Nanotechnology may be used to create drug products in which nanomaterials (as explained in section II of this document), serve a variety of functions, as active ingredients4 or inactive ingredients, including carriers loaded with an active ingredient. 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 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.

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All written comments should be identified with this document's docket number: FDA-2017-D-0759.

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