FDA Prepares To Update Drug-Induced Liver Injury Guidance
This article was originally published in The Pink Sheet Daily
A March stakeholder conference is set to consider questions unresolved by the agency's two-year-old guidelines.
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March event will look at best ways to detect and assess drug liver injury causation as agency mulls reopening the 2009 final guidance.
Agency officials, industry and academia contemplate a new approach to gauging drug-induced liver injury by using individual patients’ baseline liver enzyme measurements, a move that some say could eliminate problems with the use of the upper limit of normal and allow for the assessment of DILI in cases where there is underlying liver injury.
Company has sent a "Dear Dr." letter describing rare cases of liver problems and will also send additional data to FDA from the clinical trials.