Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay...
The FDA Drops New Laboratory Test Regulations
Laboratory-developed tests (“LDTs”) are in vitro diagnostic (“IVDs”) products designed and used within a single clinical laboratory to perform high complexity testing. These tests can identify a wide range of issues...
Keeping Up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions) to provide recommendations...
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