FDA发布含纳米材料的人用药品及生物制品最终指南（FDA-2017-D-0759）
Drug Products, Including Biological Products, that Contain Nanomaterials
FDA发布编号FDA-2017-D-0759的最终指南，针对成品剂型中含纳米材料的人用药品（包括生物制品）的开发提供建议。指南指出纳米材料可作为活性成分或非活性成分，包括载有活性成分的载体，并可能使产品属性不同于不含此类材料的产品。该文件由CDER发布，公众可随时在线或书面提交意见，书面意见须注明文件编号FDA-2017-D-0759。
最终指南说明成品剂型含纳米材料的人用药品（含生物制品）的开发考量，并列出可随时提交意见的渠道。
GUIDANCE DOCUMENT
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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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2017-D-0759.
来源：FDA Pharmaceutical Quality Documents · fda.gov