Boston Business Journal

FDA Warns Brigham of ‘Significant Violations' at Drugmaking Site

The federal Food and Drug Administration has issued a warning letter to Brigham and Women’s Hospital’s drug manufacturing facility in the Boston hospital over “significant violations” to the agency’s manufacturing regulations for its positron emission tomography (PET) drugs.

PET drugs combine nuclear medicine and biochemical analysis to measure metabolic activity of the cells of body tissues, according to Johns Hopkins. They are used in patients with brain or heart conditions and cancer and help visualize the biochemical changes in the body. 



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