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FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests
On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the same enforcement approach as other in vitro diagnostic (IVD) products. FDA had previously issued the proposed rule in September of last year….By:…
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FDA Finalizes Rule Regulating Laboratory Developed Tests
FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of these tests. This landmark rule was finalized with lightning speed, with the Proposed Rule published in the Federal Register on October 2, 2023….By: Polsinelli
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NIST Releases New Draft Guidance to Improve Safety, Security and Trustworthiness of AI Systems
The flurry of AI-related activity has certainly begun. Earlier this week, the Department of Commerce’s National Institute of Standards and Technology (NIST) released new draft guidance to improve the safety, security and trustworthiness of AI systems….By: Manatt, Phelps & Phillips, LLP
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[Video] Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 190: Healthcare Tech and Human Resources with Shannon Frazier, HR Executive Director at Lenovo
On this episode, Heather and Lauren welcome Shannon Frazier, the Executive Director of Human Resources for Lenovo North America, a Fortune 500 company and the world’s leading PC maker. They discuss how Lenovo’s products protect electronic medical records, AI developments in the workplace, and their support of the upcoming North Carolina Technology Day on May…
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Understanding Tallahassee’s Traffic Accident Trends and How They Affect You
Traffic is a risk for motorists, cyclists and pedestrians on Tallahassee’s roads. Traffic accidents are among the leading causes of traumatic injuries—and they are among the most common reasons why local residents need to hire a Tallahassee injury attorney……By: Searcy Denney Scarola Barnhart & Shipley
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Negotiators Arrive in Cairo as Israel Seizes Rafah Crossing
Hamas and Israeli officials traveled to Egypt to restart cease-fire talks, hours after the Israeli military sent tanks into southern Gaza in what it called a limited operation.
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On European Tour, Xi Jinping Heads to Friendly Territory in the East
After leaving France later Tuesday, the Chinese leader landed in Serbia and will visit Hungary, two countries whose authoritarian leaders offer a haven for China as tensions grow over the war in Ukraine.
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Isolated From West, Putin Projects Domestic Power at Inauguration
The event for the Russian president, who claimed his fifth term in a rubber-stamp election, included a church service that underscored efforts to give a religious sheen to his rule.
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Macron Hosts Xi Jinping, China’s President, in the French Pyrenees
The French president took Xi Jinping to his childhood haunts high in the Pyrenees, hoping to forge a bond. If only the weather had cooperated.
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The New Players in Brazilian Politics? Elon Musk and Republicans.
The billionaire businessman and House Republicans have given new life to former President Jair Bolsonaro by attacking Brazil’s Supreme Court.