FDA Announces Guidance for Biomarker-Total Kidney Volume in Treatment of Autosomal Dominant Polycystic Kidney Disease

Summary

The FDA has released a guidance for industry that outlines the use of total kidney volume as a prognostic biomarker to identify patients with autosomal dominant polycystic kidney disease at high risk of progressive decline in renal function, allowing for expedited review of investigational new drug applications and other submissions.