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


In Multinational Trials, U.S. Often Lags In Efficacy, FDA Analysis Finds

Executive Summary

As drug developers continue to move clinical trials overseas, FDA is keeping a close eye on the differential results that sometimes arise between U.S. and foreign subject populations, potentially affecting the usability of hard-won data for drug applications.

You may also be interested in...

Clinical Data Quality As Good in Developing World As in Developed World – Study

Concerns that sites located in the developing world may not produce reliable data do not appear to be justified, judging by the rate of queries from sponsors to such sites.

Are U.S. And Russian Opioid Abusers Comparable?

Vivitrol's Opioid Abuse Claim Will Likely Need Monitoring and Support Services

FDA's Psychopharmacologic Drugs Advisory Committee voted in favor of expanding the indication for Alkermes' alcoholism treatment by lopsided margins, with the caveat that monitoring and support must be provided to patients.

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