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FDA Publishes Final Guidance for Industry on Nanomaterials in Drug Products
28. April 2022
The U.S. Food and Drug Administration (FDA) has published the final guidance document for industry “Drug Products, Including Biological Products, that Contain Nanomaterials” . FDA states that the guidance applies broad array of FDA-regulated products such as human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug products containing nanomaterials through abbreviated pathways, as well as considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production.