1. Format and content of a REMS document: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2023 Subject(s): Biological ProductsConsumer Product Safety -- legislation & jurisprudenceDrug IndustryGovernment RegulationRisk Evaluation and MitigationUnited StatesUnited States. Food and Drug Administration
2. 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.
3. 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
4. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020 Subject(s): Coronavirus Infections -- epidemiologyPandemicsRisk Evaluation and MitigationUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
