What If FDA Actually Shuts Down?
As “funding lapse” for US FDA continues, agency continues to triage programs to maximize its ability to protect public health and safety. Is that laudable approach actually counterproductive?
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FDA's two recent advisory committee meetings at its White Oak campus offer no obvious clues that agency is struggling due to dwindling carryover balances and furloughed employees.
Shutdown Week Four: FDA Maintains Pre-Shutdown Output Pace In Some Cases
ANDA and NDA/BLA supplement approvals continue thanks to carryover user fee funds, but US FDA hasn't made any NDA and BLA approvals during shutdown as as anxiety over effect of "lapse period" on agency increases.
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.