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Leaving FDA, Califf is unapologetic — and warns of staff departures
In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...
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When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
Johnson & Johnson Gets FDA Fast-Track Designation for Posdinemab in Alzheimer's
The New Brunswick, N.J., pharmaceutical giant said posdinemab has shown potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer's patients, and in ...
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
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Departing FDA Head Defends Agency’s Record, Looks Warily Ahead
Speaking with Stat ahead of his exit, Robert Califf expressed concern about the potential for brain drain in government. Other news is on promising drugs for lung cancer patients, the upcoming J.P.