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NIH suspended operations in two of their production facilities due to the preliminary findings of internal evaluations: a cell thera- py production facility and a facility that produces positron emission tomography (PET) materials. Although no evidence has been found of patient harm, a rigorous clinical review will be undertaken, and no new patients will be enrolled into affected trials, NIH stated. These developments come after serious problems were identified with the facilities last year.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
