Pink Sheet 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


FDA Open To Revising Guidance On Drug-Induced Liver Injury

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Good drugs can be held responsible for bad things happening to the liver if sponsors do not fully explore alternate explanations for liver toxicities that turn up in a clinical trial, cautions John Senior, associate director for science in CDER’s Office of Surveillance and Epidemiology.

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 Panel To Weigh Unmet Need Vs. Liver Injury With Samsca Kidney Indication

Risk of drug-induced injury is likely to complicate an Aug. 5 advisory committee review of Otsuka’s kidney drug tolvaptan.

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


Latest Headlines
See All



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