FDA Bridging for Drug-Device and Biologic-Device Combination Products Draft Guidance for Industry
标准简介
Bridging for Drug-Device and Biologic-Device Combination Products Draft Guidance for Industry[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Bridging for Drug-Device and Biologic-Device Combination Products Draft Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft—Not for Implementation 1 Bridging for Drug-Device and 2 Biologic-Device Combination Products 1
3 Guidance for Industry 4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 This guidance provides recommendations to industry and FDA staff on how to approach 20 bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-
21 device and biologic-device single entity or copackaged combination products including the 2
22 following: 23 24 • Bridging of information related to a combination product that employs a different device 3 4
25 constituent part or parts with the same drug constituent part or parts as the proposed 26 combination product 27 1
This guidance has been prepared by the Office of Surveillance and Epidemiology and the Office of New Drugs in the Center for Drug Evaluation and Research, in cooperation with the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Combination Products at the Food and Drug Administration. This guidance is one of several documents FDA is issuing to fulfill the performance goals under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). 2
See section 503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the definition of combination products in 21 CFR 3.2. 3
See constituent part definition in 21 CFR 4.2. 4
For purposes of this guidance, except where specifically indicated, references to drug or drug constituent part or parts include a drug or biological product constituent part submitted as part of a combination product for approval or approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or licensed under section 351(a) of the Public Health Service Act (PHS Act). Some of the principles applicable to products submitted for approval under section 505(b) of the FD&C Act or licensure under section 351(a) of the PHS Act may also be applicable to products submitted for approval under section 505(j) of the FD&C Act or licensure under section 351(k) of the PHS Act. In addition, the scientific principles discussed in this guidance may be applicable to combination product submissions under sections 515, 513(f)(2), or 510(k) of the FD&C Act. 1
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