FDA sets out clinical trial safety rules

The FDA has announced its new rules for clinical trials. Clinical trial moderators now have 15 days to inform the FDA of higher adverse reactions and risks to participants. "This final rule will expedite FDA's review of critical safety information and help the agency monitor the safety of investigational drugs and biologics," says Rachel Behrman, Associate Director for Medical Policy in the FDA's Center for Drug Evaluation and Research, in a statement. FDA release | Story

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