HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US RSS
 
Welcome to FDAweb
Pay Per View
Search our 66,082 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
     
 
Guidance on Planning/Design of Multi-Regional Trials
09/09/2016
 

Federal Register Notice: FDA is making available a draft guidance entitled E17 General Principles for Planning and Design of Multi-Regional Clinical Trials. It was prepared under the auspices of the International Council for Harmonization. Multi-regional clinical trials (MRCTs) conducted according to the guidance will investigate treatment effects in overall populations with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guidance entitled E5 Ethnic Factors in the Acceptability of Foreign Clinical Data (E5 guidance)) The trials will evaluate the consistency of treatment effects across populations. The draft guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines. To download this guidance, click here. To view this notice, click here.

 
 
 
Any copying or electronic transfer without written permission is strictly prohibited and will result
in termination of service and prosecution under the federal Copyright Act.
To gain permission to copy this article log on to http://www.copyright.com.

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com