US FDA exempts Phase I drugs from GMP rules
This article was originally published in Scrip
Executive Summary
Phase I drugs that have not been previously marketed or tested in later-stage clinical trials will be exempt from complying with current good manufacturing practice regulations, the US FDAsays in a final rule. The change is aimed at streamlining drug development by applying manufacturing standards that are more appropriate and meaningful for drugs and biologicals used in early-stage clinical trials.