federal_register: 2016-11438
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-11438 | Considerations for Use of Histopathology and Its Associated Methodologies To Support Biomarker Qualification; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification." This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical biomarker qualification studies in which histopathology is used as a reference or truth standard. This guidance discusses the processes that we recommend be considered when generating histopathology data to be included in biomarker studies and outlines the scientific standards recommended for histopathology used in nonclinical biomarker characterization and qualification. The recommendations in this guidance are intended for confirmatory studies in nonclinical biomarker qualification that justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histopathologic changes is essential. The principles outlined in this guidance are also applicable to exploratory nonclinical biomarker studies. This guidance finalizes the draft guidance "Use of Histology in Biomarker Qualification Studies," issued in December 2011. | 2016-05-16 | 2016 | 5 | https://www.federalregister.gov/documents/2016/05/16/2016-11438/considerations-for-use-of-histopathology-and-its-associated-methodologies-to-support-biomarker | https://www.govinfo.gov/content/pkg/FR-2016-05-16/pdf/2016-11438.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification." This guidance is intended to... |