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The study of one PDI agent (FG 2216) was halted temporarily after a report of death from fulminant hepatitis, but the other (FG 4592) continues to be studied in a phase 2 clinical trial

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Lower concentrations spread the peptide across more water, making precise small doses easier to measure but requiring larger injection volumes

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The agency said the practices raise significant regulatory and public health risks, leading it to monitor the safety and legal implications of the activities