FDA于2016年5月公布了“使用組織病理學(xué)及其相關(guān)方法支持生物標(biāo)志物鑒定應(yīng)考慮的問題”指導(dǎo)原則。該指導(dǎo)原則概述了組織病理學(xué)非臨床生物標(biāo)志物的特點(diǎn)，詳述了這種非臨床生物標(biāo)志物鑒定中使用組織病理學(xué)方法的科學(xué)標(biāo)準(zhǔn)。本文介紹該指導(dǎo)原則的主要內(nèi)容，期望對(duì)我國(guó)這方面的研究和監(jiān)管有所幫助。

FDA issued Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry in May 2016. The guideline outlined the characteristics of nonclinical biomarker of histopathology, and explained the scientific standards for the use of histopathological methods in the nonclinical biomarker qualification. This paper introduces the main contents of the guideline, and it is expected to be helpful to the research and supervision in our country.