FDA's Oncology Advisory Committee Mulls Tighter ESA Label
This article was originally published in The Pink Sheet Daily
Executive Summary
March 13 panel takes up FDA proposals for Amgen, J&J risk management, too.
You may also be interested in...
ODAC Calls For Additional EPO Trials To Support Continued Use In Oncology
In the absence of data on approved therapeutic target, panel advises adding warnings from signals in off-label use to label.
NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications
New Look At Ezetimibe Fails To Confirm Vytorin Cancer Signal
Interim data from SHARP and IMPROVE-IT trials fail to show evidence of impact on cancer rates.