What new DOGE firings at the FDA could mean for food safety and medical devices
The firings appeared to focus on employees in the agency’s centers for food, medical devices, and tobacco products. The Trump ...
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FDA’s head of device safety among employees terminated in ‘challenging’ weekend
The cuts hit the FDA's medical device center particularly hard, including reviewers and experts on AI-enabled medical ...
Teva and Alvotech get FDA review acceptance for its proposed biosimilar to Eylea
Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application ...
Alvotech and Teva’s BLA filing for AVT06 accepted by FDA
Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) announced that the FDA has accepted for review a Biologics License Application, or BLA, for ...
Why Quaker Oats Waffle Recall Set To FDA’s Highest Risk Level
FDA updates Quaker Oats' pancake & waffle mix recall to Class I, its highest risk level, due to undeclared milk. Check if ...
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HKU team develops AI-driven tool to accelerate cancer diagnosis
A research team led by Professor Kevin Tsia, programme director of the Biomedical Engineering Programme under the Faculty of Engineering of the University of Hong Kong (HKU), has developed an ...
Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
Anti-Kickback Statute: A Powerful Tool in DOJ’s Corporate Arsenal Grows Stronger
This article discusses the Anti-Kickback Statute and the False Claims Act. "When coupled with the False Claims Act (FCA), the AKS turns into a potent civil enforcement tool that carries many of the ...
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AI tool predicts response to, survival after treatment with immune checkpoint inhibitors
An AI tool appeared superior to two FDA-approved biomarkers for predicting how people with cancer will respond to immune ...