The US Food and Drug Administration’s (FDA’s) independent evaluation of medical products for safety and effectiveness prior to granting approval for marketing or new labeled indications is fundamental to assuring the public and clinicians that marketed products have a positive balance of benefit to risk when used according to labeling. Ever since this foundational protection was established in 1962, a body of evidence has supported the use of a flexible but consistent standard when making decisions about marketing approval: Do the benefits of a product outweigh the risks when used as intended and labeled?
Califf RM. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. JAMA. 2017;317(7):693–694. doi:10.1001/jama.2017.0410
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