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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

Pathology Matters, part 2 of a 3 part series: Assessing Histopathology Results

Part 1 of this series described the preclinical study types relying heavily on histopathology data: device safety, biocompatibility, and systemic toxicity. Here we focus on strategies for histopathology data assessment. Preclinical study histopathology data can generally be divided into three types: Qualitative Quantitative Semiquantitative Qualitative histopathology uses description to document tissue changes and is more […]

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Pathology Matters, part 1 of a 3 part series: Preclinical Studies and Histopathology

The histopathology evaluation in preclinical studies is performed to support the study objectives. The study type, tissues examined, and intended data use all determine what pathology analysis is needed. Here we review the preclinical studies that rely heavily on histopathology data. Histopathology is a key component of these preclinical study types: Device safety studies Biocompatibility […]

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preclinical

FDA CDRH Experiential Learning Program is open for comments

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 23, 2017 that the submission period for Experiential Learning Program (ELP) in open. ELP is a training component intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other […]

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