US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008–2022)

20260 citationsJournal Articlehybrid Open Access

Authors

Elaine H. Morrato · Colorado School of Public Health

Elizabeth J. Campagna · Statistical Research (United States)

Cynthia LaCivita · University of the Potomac

Gita A. Toyserkani · Kaiser Permanente Walnut Creek Medical Center

Abstract

REMS modifications were common and demonstrated responsiveness to new evidence about the drug and adaptation to changing patterns of healthcare delivery within a learning health system.

Topics & Keywords

Pharmacovigilance and Adverse Drug Reactions Drug-Induced Adverse Reactions Biosimilars and Bioanalytical Methods

Publication Details

Published in: Drug Safety

DOI: 10.1007/s40264-026-01654-w

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US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008–2022)

Authors

Abstract

Topics & Keywords

Publication Details