Federal Register #2026-09533

FDA Request for Information on Urinary Kidney Safety Biomarkers

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking information from stakeholders regarding urinary kidney safety biomarkers for drug-induced kidney injury (DIKI): - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) or vendors are named in this notice - Requested Information: - Data and input on urinary kidney safety biomarkers, including: - General food categories where BHT is used - Typical and maximum use levels of BHT - Data on migration from food contact materials - Biomonitoring and safety data relevant to BHT and urinary kidney safety biomarkers - Datasets in CDISC format (including clinical, demographic, pharmacokinetic, and biomarker data) - Assay descriptions and validation reports - Unique or Notable Requirements: - Focus on advancing biomarker validation for DIKI - Emphasis on data sharing and broader translation among stakeholders - Submissions should include comprehensive datasets and supporting documentation - No products or services are being procured; this is an information-gathering request to support regulatory science initiatives

Description

This is a request for information by the Food and Drug Administration (FDA) regarding a regulatory science initiative focused on biomarkers of drug-induced kidney injury. The initiative aims to advance biomarker validation and data sharing among stakeholders. The FDA is seeking comments and data submissions related to urinary kidney safety biomarkers to inform future activities related to biomarker development and translation. Comments must be submitted by July 13, 2026.

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