Pink Sheet is part of the Business Intelligence Division 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
UsernamePublicRestriction

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.
Advertisement

Related Content

Clinical Data Quality As Good in Developing World As in Developed World – Study
Are U.S. And Russian Opioid Abusers Comparable?
Are U.S. And Russian Opioid Abusers Comparable?
Vivitrol's Opioid Abuse Claim Will Likely Need Monitoring and Support Services
Toprol-XL Eyed As Precedent For Brilinta Labeling On U.S. Efficacy Data
Foreign Clinical Trials: FDA Oversight To Include More Training, Data Collection

Topics

Advertisement
UsernamePublicRestriction

Register

PS052671

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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