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FDA Aligns U.S. Medical Device Quality System Regulation with International Standards
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with internationally accepted standards set forth in ISO 13485:2016. In the final rule, FDA reframes FDA’s QSR under the new monicker, “Quality Management…
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Senators Propose Clarification of Antitrust Law to Expressly Cover Algorithmic Collusion — AI: The Washington Report
1. Following up on a December 2023 hearing on algorithmic price-fixing and self-preferencing, Chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights Amy Klobuchar (D-MN) introduced a bill entitled the Preventing Algorithmic Collusion Act. 2. Under the terms of this bill, a price-fixing agreement would be presumed “when direct competitors share…
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Shaping the Digital Future: The Newly Adopted EU Data Act and Its Impact
In the rapidly evolving digital landscape, the European Union’s Data Act (Data Act), adopted on November 27, 2023 marks a significant shift in data, privacy, and intellectual property regulation. The Data Act applies to manufacturers of connected devices (such as IoT and medical devices, but also connected vehicles). Among other entities, it also applies to…
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UNRWA in Gaza Fought Hamas Infiltration; Not Hard Enough, Israel Says
The main U.N. agency in Gaza said it has long investigated claims of links, firing several employees over the years. Israel says it is a compromised organization too weak to protect itself.
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Shocking Opposition Victory Throws Pakistan Into Chaos
The party of Imran Khan, the jailed former prime minister, took the most seats, humiliating the country’s military rulers and creating a political crisis.
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Egypt Warily Eyes Gaza as War Builds Pressure on Its Border
Egypt has reinforced its frontier with Gaza and warned Israel that any move that would send Gazans spilling into Egyptian territory could jeopardize their decades-old peace treaty.
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On a Frozen Border, Finland Puzzles Over a ‘Russian Game’
As it votes on Sunday for a new president, NATO’s newest member says Moscow is testing it by turning asylum seekers into a political pressure point.
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China Keeps Building Stadiums in Africa. But at What Cost?
This year’s Africa Cup of Nations, like several previous editions, played out in Chinese-built arenas. It will end with familiar questions about their legacy.
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Fragments of Asteroid With Mystery Origin Are Found Outside Berlin
Astronomers tracked the entry of a small space rock into Earth’s atmosphere, and then meteorite hunters made an unexpected discovery.
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10 rom-com-inspired recipes to warm the heart
We’ve included dishes from our favorite rom-coms, including spaghetti carbonara, tiramisu, lamb chops and pigs in a blanket.