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

UsernamePublicRestriction

Drug-Induced Liver Injury Workshop Offers More Questions Than Answers

Executive Summary

To fully understand an experimental drug's potential for liver toxicity, clinical trials should be better designed to reflect real-world populations, including patients with liver disease, but neither FDA nor experts from industry and academia at a recent workshop on the topic were able to provide many answers on how to do so safely

You may also be interested in...



PhRMA’s “I’m In” Campaign Looks To Connect Minorities To Studies

Extension of the Clinical Trial Engagement Network is aimed at increased diversity in clinical trials, which is becoming increasingly important as more drugs are targeted at specific groups.

FDA To Be More Vigilant About Proposed Clinical Trial Exclusions

FDA’s Bob Temple says “document” being drafted will instruct reviewers to pay more attention during sponsor meetings and eliminate unnecessary exclusions from protocols.

Patient Exclusion Analysis Coming From FDA; Changes In Trial Recruitment Could Follow

Subjects with psychiatric conditions are often excluded from trials, an agency study finds, which “doesn’t seem a good thing” to Bob Temple.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS049476

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