Framework to Evaluate Science Behind Regulatory Submissions
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May 12, 2010 -- The studies that food, drug, and device companies submit to the U.S. Food and Drug Administration to support statements about the benefits of their products often look at effects on intermediate biological benchmarks that substitute for actual clinical outcomes. A new report by the Institute of Medicine recommends a framework that the FDA can use to rigorously and consistently evaluate the validity and appropriateness of these biomarkers.
