No Dispute Over Safety-Related Label Updates; Does FDA Hold All The Cards?
Executive Summary
A new dispute resolution process for product labeling updates may see little action given the drug safety liability pressures from outside FDA, Lauren Silvis, an associate in Sidley Austin's Food and Drug Practice, said
You may also be interested in...
FDA’s Labeling Rule Should Be Tweaked, Firms Say; Dems Want It Squashed
FDA appears to have a relatively smooth task ahead of itself as it works to finalize its proposed rule delineating when firms can change product labels without prior agency approval since the comments supporting the proposal contain few suggested changes
NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance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.