US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008–2022)
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.
Institutions
- Colorado School of Public Health (US)
- Loyola University Chicago (US)
- University of the Potomac (US)
- Kaiser Permanente Walnut Creek Medical Center (US)
- Statistical Research (United States) (US)
- Oldham Council (GB)
Publication Details
- Journal
- Drug Safety
- Published
- 2026-03-24
- DOI
- https://doi.org/10.1007/s40264-026-01654-w
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00