> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CDER Wants Info for Kidney Safety Biomarker Pilot
- URL: https://www.fdaweb.com/cder-wants-info-for-kidney-safety-biomarker-pilot/
- Published: 2026-05-12T12:00:00.000Z
- Updated: 2026-09-14T13:39:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161131

CDER is requesting information for a planned regulatory science initiative to advance biomarker validation through the compilation of data from multiple sources and through a specific pilot project focused on aggregating data for biomarkers of drug-induced kidney injury. A 5/13 *Federal Register* [notice](tps://public-inspection.federalregister.gov/2026-09533.pdf) says ultimately, improving CDER’s ability to evaluate novel biomarkers could facilitate the generation of higher-quality biomarker data, expanded use of novel biomarkers, more consistent interpretation of findings from biomarker studies, and development of novel endpoints that can support a range of regulatory and drug development decisions.

The notice says that under this Biomarker Incubator initiative, the agency has focused on advancing the use of biomarkers of drug-induced kidney injury as a pilot project. It says the project’s specific objectives are to:

- assess data availability and quality;
- pool data from a range of clinical trial participants, drug programs, and phases of development;
- perform analyses characterizing intersubject and intrasubject variability, expected ranges for subpopulations, time-course for changes, use and quality of different assay methodologies, and the predictive performance compared to conventional biomarkers; and
- establish a process and platform for identifying, requesting, receiving, storing, and analyzing data to support biomarker use in drug development.

“This request for information aims to provide an opportunity for stakeholders — including both commercial drug developers and academic investigators — to share with FDA deidentified subject-level data on these biomarkers and experiences and challenges in applying these biomarkers in drug development,” the notice says.