HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Liver Injury Conference Another Chance To Inform Guidance Changes

This article was originally published in The Pink Sheet Daily

Executive Summary

March event will look at best ways to detect and assess drug liver injury causation as agency mulls reopening the 2009 final guidance.

You may also be interested in...



Jurassic Products: FDA Resurrects Withdrawn Drugs To Study Liver Injury

Agency soliciting contractor to produce 37 drugs withdrawn because of liver injury; goal is developing better tools for evaluating compounds in the pipeline.

FDA Could Shift Assessment Of Drug-Induced Liver Injury In Clinical Trials

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.

FDA Prepares To Update Drug-Induced Liver Injury Guidance

A March stakeholder conference is set to consider questions unresolved by the agency's two-year-old guidelines.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076927

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel