News & Events
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June 10, 2008
FDA & EMEA to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. -
June 10, 2008
C-Path Leads Novel Transatlantic Drug Safety Effort
Companies receive go ahead from FDA and EMEA to use new improved tests when assessing safety of new drugs. -
April 10, 2008
FDA Soon May Support Biomarker Tests
The Food and Drug Administration is poised to throw its support behind a powerful new method of predicting the safety of experimental drugs, a step that could help pharmaceutical companies bring treatments to market more quickly – and reduce patients’ risk. - March 20, 2008
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March 10, 2008
US News & World Report – Genetic Tests Predict Response to Warfarin
Variations of a gene that determines a person’s sensitivity to warfarin are important in determining the initial doses of the anti-clotting drug, researchers report.
