Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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 Prepares To Update Drug-Induced Liver Injury Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

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

You may also be interested in...



FDA Liver Injury Conference Another Chance To Inform Guidance Changes

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

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.

Where A REMS Didn't Help: Sanofi Must Deal With Liver Injuries With Multaq

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS071745

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