Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration
David Croteau, Ellen Pinnow, Eileen Wu, Mónica Muñoz, Ilynn Bulatao, Gerald J. Dal Pan
Topics & Concepts
MedicineAdverse Event Reporting SystemFood and drug administrationDrug labelingDrugMedical prescriptionPatient safetyAdverse effectPrescription drugMedical emergencyFamily medicinePharmacologyHealth careEconomicsEconomic growthPharmacovigilance and Adverse Drug ReactionsPharmaceutical industry and healthcareComputational Drug Discovery Methods