July 26th, 2010
Questions for Sanjay Kaul about TIDE and Avandia
Sanjay Kaul, MD and Harlan M. Krumholz, MD, SM
CardioExchange’s editor-in-chief Harlan Krumholz discussed the TIDE trial on email with Sanjay Kaul, who was a member of the FDA’s advisory panel last week on Avandia. Here is a lightly edited version of their exchange. Krumholz: What is your response to the FDA announcement that it has placed TIDE on a “partial clinical hold”? Do you […]
July 21st, 2010
FDA Halts New Enrollment in TIDE
Larry Husten, PHD
The FDA has halted new enrollment in TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation), the controversial Avandia safety study, by placing the study on “partial clinical hold.” Patients already enrolled in the trial will continue to participate. The FDA said in a statement that it had instructed GlaxoSmithKline to “update investigators, institutional review boards (IRBs) and ethics committees […]
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