FDA, EMEA Consider Seven New Toxicity Tests

June 19, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration and the European Medicines Agency will collaborate in efforts that would allow drug companies to submit results of seven new drug-safety tests.

Rockville, MD (June 12)-The US Food and Drug Administration and the European Medicines Agency will collaborate on efforts that would allow drug companies to submit results of seven new drug-safety tests.

These tests measure the levels of seven biomarkers that would provide information regarding renal toxicity or kidney-cell damage and would supplement the already-required blood urea nitrogen test and the serum creatinine test. The new biomarkers are KIM-1, albumin, total protein, beta2-microglobulin, cystatin c, clusterin, and trefoil factor-3.

"The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, in a prepared statement. "We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible and help healthcare professionals better manage potential kidney damage from drugs."

The consideration of additional tests is part of a new framework emphasizing collaboration between FDA and EMEA on drug safety.