FDA Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA Draft

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Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA Draft[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。

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Draft — Not for Implementation 1 Comparative Analyses and Related Comparative Use Human 2 Factors Studies for a Drug-Device Combination Product Submitted 3 in an ANDA: 1

4 Guidance for Industry 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 This guidance is intended to assist potential applicants who plan to develop and submit an 18 abbreviated new drug application (ANDA) to seek approval of a proposed combination product 2

19 that includes both a drug constituent part and a delivery device constituent part. The 20 recommendations included in this guidance generally focus on the analysis of the proposed user 3

21 interface for the generic drug-device combination product (generic combination product) when 22 compared to the user interface for the reference listed drug (RLD). For the purposes of this 23 guidance, the term user interface refers to all components of the combination product with which 24 a user interacts. This includes the delivery device constituent part of the combination product 25 and any associated controls and displays, as well as product labeling and packaging. 26 27 In the early stages of development, potential applicants should carefully consider the design of 28 the user interface of a proposed generic combination product and seek to minimize differences 29 from the user interface for the RLD. To facilitate that process, this guidance provides general 30 principles, including how to conduct threshold analyses for the identification and the assessment 31 of differences in the design of the user interface for the proposed generic combination product 32 when compared to its RLD. 33 34 Depending on the results of the threshold analyses discussed in this guidance, submission of 35 additional data may be warranted, such as data from comparative use human factors studies, to 36 assess the acceptability of differences identified in the user interface for the proposed generic 1

This guidance has been prepared by the Office of Generic Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research (CDER), with the assistance of the Office of Combination Products and the Center for Devices and Radiological Health at the Food and Drug Administration. 2

Products that include both a drug constituent part and a device constituent part are regulated as combination products. See 21 CFR Parts 3 and 4. Combination products within the scope of this guidance are those with a drug primary mode of action. Therefore, CDER will have primary jurisdiction for the review of these combination products and will coordinate with the Center for Devices and Radiological Health as appropriate. 3

The term generic in this guidance refers to a product for which approval is sought under an ANDA.

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