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FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals

Leila G. Lackey, Graham C. Thompson, Sara Eggers

2020Therapeutic Innovation & Regulatory Science25 citationsDOIOpen Access PDF

Topics & Concepts

DrugContext (archaeology)Risk analysis (engineering)MedicineFood and drug administrationPharmacyHuman immunodeficiency virus (HIV)Flexibility (engineering)PharmacologyDrug approvalOrphan drugFamily medicineBioinformaticsManagementBiologyPaleontologyEconomicsPharmacovigilance and Adverse Drug ReactionsHealth Systems, Economic Evaluations, Quality of LifePharmaceutical industry and healthcare
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