1. An analysis of reported adverse drug reactions Author(s): O'Connor, Michael, authorGrissinger, Matthew, author Publication: [Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, [2014] Subject(s): Drug-Related Side Effects and Adverse Reactions -- epidemiologyDrug-Related Side Effects and Adverse Reactions -- prevention & controlContrast Media -- adverse effectsDrug TherapyMedication Therapy ManagementPrescription Drugs -- adverse effectsRisk FactorsRisk ManagementHumansPennsylvaniaUnited States
2. REMS: FDA's application of statutory factors in determining when a REMS is necessary Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2019 Subject(s): Drug Evaluation -- legislation & jurisprudenceRisk Evaluation and Mitigation -- legislation & jurisprudenceCost of IllnessDrug-Related Side Effects and Adverse ReactionsHealth Services AccessibilityPrescription Drugs -- adverse effectsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.