1. Risk evaluation and mitigation strategies: modifications and revisions Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020 Subject(s): Drug ApprovalDrug IndustryDrug LabelingRisk Evaluation and MitigationUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020 Subject(s): Drug ApprovalRisk Evaluation and MitigationUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
