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Final FDA SIUU Guidance: Understanding the Key Updates and Resources
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
FDA pauses updates on foodborne outbreak probes
Multiple federal health agencies have stopped releasing some key health information — including updates on some outbreak ...
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FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
JD Supra4d
Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
CNN on MSN6d
Trump administration directs federal health agencies to pause communications
Amid a deluge of executive actions, the Trump administration has directed federal health agencies to pause external ...
ophthalmologytimes3d
Pantheon Vision completes third pre-submission meeting with the FDA
The meetings support the company’s submission for its bioengineered corneal implants to eliminate corneal blindness.
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Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
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Scope of the communications hold on federal health agencies expands
"National security, public health, and medical care rely on the accurate and rapid collection and communication of ...
Pantheon Vision Announces Third Successful Meeting with the FDA Review Team
Corneal blindness affects more than 13 million people worldwide and more are waiting for corneal transplants. Human donated tissue has less than 50% success rate at five years. Other challenges ...
Trump Administration Temporarily Mutes Federal Health Officials
Scientific meetings were canceled, and research data on the bird flu outbreak was delayed, amid confusion over the directive.
Trump's freeze on health agency communications leads to cancellation of scientific meetings
The Trump administration’s freeze on communications from U.S. health agencies is leading to another disruption: the abrupt cancellation of scientific meetings. The move covers a swath of health ...