FDA and Europe Adopt Joint Drug Policy
Posted on: Thursday, 12 June 2008, 15:00 CDT
The U.S. Food and Drug Administration and the European Medicines Association say they plan to work together in assessing the safety of new drugs.
In the first use of a framework allowing submission of a single application to the two agencies, the two regulatory organizations worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs.
The tests measure the levels of key proteins found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.
We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible &133;, said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Woodcock said such human tests might lead to more powerful drugs, especially for diseases in which renal toxicity currently prevents promising experimental drugs from being approved.
The project is the first in which drug companies propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration.
Source: United Press International
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