FDA Safety Reports: Firms Want Advance Notice Before Public Release
This article was originally published in The Pink Sheet Daily
PDUFA renewal could establish process that allows firms early warnings about Sentinel and other safety data announcements.
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Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.
Fee structure changes and process enhancements floated during opening session between industry and agency.
The agency announces that it is evaluating unpublished findings based on pancreatic tissue specimens from a few deceased patients; clinicians say ongoing prospective studies will determine how diabetes drugs affect the pancreas.