Document is current
Any future updates will be listed below
-
Authors
Toyserkani, Gita A. https://orcid.org/0000-0002-6946-6138
Robottom, Suzanne B.
Morrato, Elaine H. https://orcid.org/0000-0001-6105-7826
-
Funding
Funding for this research was provided by:
U.S. Food and Drug Administration (IPA Contract)
National Institute of Health (2UL1TR002389-06)
National Institutes of Health (UL1TR002535)
- License Information
-
More Information
Article History
Accepted: 26 February 2025
First Online: 9 April 2025
Declarations
:
: EM received financial support from the US FDA, Office of Surveillance and Epidemiology, through an Intergovernmental Personnel Act contract administered with the University of Colorado, USA. EM was also supported by the National Center for Advancing Translation Science of the National Institutes of Health under award numbers 2UL1TR002389-06 and UL1TR002535.
: Over the past 3 years, EM has served as a consultant on issues of drug safety for Eli Lilly, i2o, Reata Pharmaceuticals, and Syneos Health and to the class plaintiffs of the Xyrem (sodium oxybate) antitrust litigation, including United Healthcare Services, Inc., Humana Inc., Molina Healthcare, Inc., and Health Care Service Corporation, Inc. and receives compensation for those services. The terms of these arrangements have been reviewed and approved by Loyola University Chicago in accordance with its policy on objectivity in research. GT and SR have no conflicts of interest to declare.
: Not applicable.
: Not applicable.
: Not applicable.
: Not applicable.
: Not applicable.
: All authors contributed to the scientific conception, design, and interpretation of the REMS logic model and helped critically revise the viewpoint. All authors read and approved the final version of the viewpoint.
