CV Adjudication Not Always Best Option To Ensure Trial Quality
Executive Summary
FDA officials indicate that getting adequate power or insight into dose response could be more beneficial in clinical trials.
You may also be interested in...
Can Iclusig Return To Market? Ariad Sees Path Through Restricted Distribution REMS
Company reluctantly agrees to FDA’s request to suspend sales of ponatinib due to serious thrombotic risks while a narrower label and Risk Evaluation and Mitigation Strategy are negotiated. FDA cites serious adverse vascular event rates of 48% and 24% in Phase I and II ponatinib trials, respectively.
Avandia Review Endorsement Aided By Good Data, Cultural Shift On Safety
Flawed clinical trial overcomes meta-analysis safety signal as mortality data from the re-adjudicated RECORD trial persuades the rosiglitazone advisory committee that the product’s risk management program can be relaxed.
Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.