Journal of drugs in dermatology : JDDDrug LabelingUnited StatesHumansUnited States Food and Drug AdministrationDermatologic Agents
FDA Boxed Warnings: Should Package Inserts Include Levels of Evidence?
Andrea Leung, Tina Bhutani, Nicholas Brownstone, John Koo
Published: 202510.36849/JDD.9122
Abstract
Many medications commonly used in dermatology come with package inserts that contain boxed warnings that are frequently not evidence-based. Boxed warnings are the most serious warnings that the US Food and Drug Administration (FDA) can issue for medi…
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