Keep Updated August 2015

FDA issues draft guidance for TKV

We continue to make good progress toward FDA support for TKV as a bio-marker for trial enrichment. I recently let you know that the FDA issued a formal letter of support to C-Path’s PKDOC (PKD Outcomes Consortium) for TKV as […]

PKD Foundation |

FDA issues letter of support for TKV as ADPKD biomarker

The U.S. Food and Drug Administration (FDA) has issued a Letter of Support to the Critical Path Institute’s (C-Path) Polycystic Kidney Disease Outcomes Consortium (PKDOC) for the use of total kidney volume (TKV) as a prognostic biomarker for clinical trials of new therapies for ADPKD. The Foundation’s […]

PKD Foundation |