Drug Safety Announcement Blitz Highlights Gottlieb's PR Savvy As Shutdown Drags On
Release of several different safety announcements showcases US FDA Commissioner Gottlieb's efforts to quell potential public concerns with an active communication strategy.
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The international group will work on harmonizing scientific and technical standards for generic drugs, which could reduce duplication and development costs.
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.
US FDA’s strategic plan for Sentinel includes pilot projects to move towards the vision of active surveillance. However, FDA is also making clear that it won’t be a quick or easy transformation.