1. 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.
