IOM: Improved Framework Needed For FDA Oversight of Drugs, Devices, Foods

The Food and Drug Administration, in regulating drugs, medical devices, foods, and nutritional supplements, needs to coordinate with other federal agencies and improve its surveillance systems to gain better understanding of the use of biomarkers, according to a new Institute of Medicine report released Wednesday. The report calls on Congress to boost the agency's authority to require further studies of drugs and devices—after they are approved—if their approval is based on studies using biomarkers as surrogate clinical outcomes.

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