FDA Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products

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Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。

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Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as “companion diagnostics” herein) to support the indicated uses 1

of multiple drug or biological oncology products, when appropriate. This guidance builds upon existing policy regarding the labeling of companion diagnostics. In a prior guidance issued in 2014, the Agency stated that if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group of therapeutic products, the companion diagnostic’s intended use/indications for use should name the specific group of therapeutic products, rather 2

than specific products. This guidance expands on the policy statement in the 2014 guidance by recommending that companion diagnostic developers consider a number of factors, including but not limited to those discussed in this guidance, when determining whether their test could be developed, or the labeling for approved companion diagnostics could be revised through a supplement, to support a broader labeling claim such as use with a specific group of oncology therapeutic products (rather than listing an individual therapeutic product(s)). For the purpose of this guidance, a specific group of oncology therapeutic products would be identified based on sufficient and consistent clinical experience with the therapeutics with the 3

same approved indications, including molecular alteration(s), for which a companion diagnostic could potentially be labeled (as discussed in this document). To illustrate FDA’s current 1

For purposes of this guidance, drug and biological oncology products are referred to as therapeutic products or oncology therapeutic products. 2

FDA’s Guidance for Industry and FDA Staff: In Vitro Companion Diagnostic Devices, August 2014, page 11, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/vitro-companion-

diagnostic-devices. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. We note that the referenced guidance includes (emphasis added) “In some cases, if evidence is sufficient to conclude that the IVD companion diagnostic device is appropriate for use with a class of therapeutic products, the intended use/indications for use should name the therapeutic class, rather than each specific product within the class.” However, in this document we use “specific group of oncology therapeutic products” rather than “therapeutic class” because depending on the indication, a specific group could be a therapeutic class, a subset of a class, or broader than a class. 3

See section IV.1 for additional information.

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