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# Nanomaterial Drug, Biologic Product Guidance
- URL: https://www.fdaweb.com/nanomaterial-drug-biologic-product-guidance/
- Published: 2022-04-21T12:00:00.000Z
- Updated: 2026-09-14T17:41:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151653

FDA has published a guidance, *Drug Products, Including Biological Products, that Contain Nanomaterials*, providing 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. The [document](https://www.fda.gov/media/157812/download?ref=fdaweb.com) says FDA does not categorically judge all products containing nanomaterials or otherwise involving the use of nanotechnology as intrinsically benign or harmful. “Rather,” it says, “for all products (nanotechnology-derived or otherwise), FDA considers the characteristics of the product and its safety and effectiveness for its use.”

FDA says the guidance finalizes a 12/18/17 draft, incorporating two noteworthy changes in response to stakeholder comments. First, the final guidance has a glossary of terminology to assist in understanding how important terms are used in it. Second, several revisions were made to reflect the agency’s current thinking on abbreviated applications, including ANDAs, for products containing nanomaterials.

The guidance contents are Introduction; Scope; Risk-Based Framework: Potential Risk Factors for Products Containing Nanomaterials; Nonclinical Studies for Drug Products; Clinical Development; Environmental Impact Considerations; and the Glossary.