WASHINGTON, May 13 -- Food and Drug Administration has issued a notice called: Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information.
The notice was published in the Federal Register on May 13 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: 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 ...