federal_register: 2011-33553
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-33553 | Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Use of Histology in Biomarker Qualification Studies." This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance discusses the processes that should be considered to ensure the quality and integrity of histology data in biomarker studies, and outlines the scientific standards for histology used in biomarker characterization and qualification. The recommendations in this guidance are intended for studies in biomarker qualification designated to justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histologic changes is essential. The principles outlined in this guidance are also applicable to exploratory biomarker studies. | 2011-12-30 | 2011 | 12 | https://www.federalregister.gov/documents/2011/12/30/2011-33553/draft-guidance-for-industry-on-use-of-histology-in-biomarker-qualification-studies-availability | https://www.govinfo.gov/content/pkg/FR-2011-12-30/pdf/2011-33553.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Use of Histology in Biomarker Qualification Studies." This guidance is intended to assist sponsors that conduct biomarker qualification... |