Using real-world safety data in regulatory approval decisions: Sotagliflozin and the risk of diabetic ketoacidosis

Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1322-1324. doi: 10.1002/pds.4994. Epub 2020 Mar 18.

Authors

Michael Fralick^{1

2}, Aaron S Kesselheim²

Affiliations

¹ Sinai Health System and the Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
² Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

PMID: 32189390
DOI: 10.1002/pds.4994

No abstract available

Publication types

Research Support, Non-U.S. Gov't

Grant support

CIHR/Canada