New England Journal of Medicine · 2008 · 350 citations · 2 references
PharmacyPharmaceutical PolicyDrug LawPharmaceutical RegulationRegulatory ScienceLabeling ComplianceMedication Labeling RequirementsPrescription RegulationRegulatory PharmacologyCoverage For Off-label UseDraft GuidanceFda Drug RegulationFda RegulationMedication Labeling RegulationOff-label Drug Use RegulationOff-label Prescribing RegulationRegulatory Prescribing Policy
Off-label prescribing is legal and common, but it is often done in the absence of adequate supporting data. Dr. Randall Stafford writes that although there is a strong rationale for greater FDA involvement in off-label use, it is moving toward relinquishing control in its new draft guidelines.
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