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

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Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry[附网盘链接]是于不久前发布的FDA标准，适用于U.S。

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Draft — Not for Implementation 1 Drug Products, Including Biological Products, 1

2 that Contain Nanomaterials 2

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug 3

18 products, including those that are biological products. Nanotechnology may be used to create 19 drug products in which nanomaterials (as explained in section II of this document), serve a 20 variety of functions, for example as active ingredients, carriers loaded with an active ingredient, 21 or inactive ingredients. The inclusion of such materials may result in product attributes that 22 differ from those of products that do not contain such materials, and thus may merit particular 23 examination. This document provides guidance on the development of human drug products, 24 including those that are biological products, in which a nanomaterial is present in the finished 25 dosage form. 26 27 Note that FDA does not categorically judge all products containing nanomaterials or otherwise 28 involving the use of nanotechnology as intrinsically benign or harmful. Rather, for all products 29 (nanotechnology-derived or otherwise), FDA considers the characteristics of the product and its 30 safety and effectiveness for its use. FDA issued a guidance document to industry on the 31 agency’s considerations related to nanotechnology applications in FDA-regulated products 1

This guidance document is one of several FDA guidance documents related to FDA-regulated products that may involve the use of nanotechnology. The use of the term “nanomaterial” in this document, as in other FDA guidance documents, does not constitute the establishment of a regulatory definition. Rather, we use this term for ease of reference only. See section II of this document for additional discussion. 2

This guidance has been prepared by the CDER Nanotechnology Working Group in the Center for Drug Evaluation and Research (CDER) with participation from the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 3

Refers specifically to those drug products that are biological products under 42 USC 262(i) and subject to licensure under section 351(a) or (k) of the PHS Act (42 U.S.C. 262(a) or (k)). See 42 U.S.C. 262(j). According to 42 USC 262(i), the term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

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