Bayer Revises Study Protocol Review To Prevent Another Trasylol Fiasco
This article was originally published in The Pink Sheet Daily
Executive Summary
Protocol Review Committee purview extended beyond prospective clinical trials based upon independent review findings.
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Trasylol Could Face Labeling Changes After Joint Advisory Panel
Long-term observational study showing CV-renal risk for Bayer’s Trasylol should be judged in light of potentially inappropriate comparator drugs, FDA says.
Trasylol Could Face Labeling Changes After Joint Advisory Panel
Long-term observational study showing CV-renal risk for Bayer’s Trasylol should be judged in light of potentially inappropriate comparator drugs, FDA says.
Bayer Suspends Senior Staffers For Failure To Disclose Trasylol Data To FDA
The company will publish findings of independent investigation, which could recommend corrective action plan.
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