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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 It considers the characterization, controls, testing, and qualification of nanomaterial components and applies to drug products that are engineered to have nanoscale dimensions. Provide the agency’s current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage
Fda will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. The fda has already reviewed and approved many nanotechnology-based products, and expects a significant increase in the use of nanoscale materials in medical products. The 2024 new drug therapy approvals report is designed to showcase cder’s role in bringing safe and effective drugs to market for patients and consumers. 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 will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction.
Fda will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction.
