FDA says PET cGMP rule coming soon
This article was originally published in The Gold Sheet
Executive Summary
FDA expects to publish a final rule this August on cGMP requirements for position emission tomography (PET) products, according to the semi-annual regulatory agenda of the Health and Human Services Department, published in the May 5 Federal Register. Section 121 of the FDA Modernization Act of 1997 directs FDA to establish cGMPs for these medical imaging drugs. The regulation would establish minimum standards for the production and testing of these products that would reflect their unique characteristics
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