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GMP REPROPOSAL IS NEEDED BEFORE REGULATION IS FINALIZED

This article was originally published in The Gray Sheet

Executive Summary

GMP REPROPOSAL IS NEEDED BEFORE REGULATION IS FINALIZED, the Health Industry Manufacturers Association argued in a Sept. 8 letter to FDA. "Before promulgating a new [good manufacturing practices regulation], the agency should issue at least one additional role that would have the status of a proposed rule and would permit further comment," HIMA suggested.
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