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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.

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