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Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or Agency) is announcing a request for information regarding a regulatory science initiative. The aims of the initiative are 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. The purpose of this notice is to inform the public of the aims of this initiative, to encourage human data submission and sharing, and to identify opportunities to enhance interactions between relevant stakeholders and FDA. The Agency intends to use the information submitted to inform future activities related to data sharing, biomarker development, and broader translation of biomarkers of drug-induced kidney injury.
- Document type
- Notice
- Federal Register document number
- 2026-09533
- Published
- May 13, 2026
- Action
- Notice; request for information.
- Docket
- FDA-2026-N-0005
- Comments posted on Regulations.gov (at last check)
- 4
- DATES section (from the document)
- Either electronic or written comments on the notice must be submitted by July 13, 2026.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2026-09533. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.