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FDA Seeks Input on Biosimilar Product Development Guidance
On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”)….By: Goodwin
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Dental Specialists Data Breach Affects an Estimated 38,442 People
On August 9, 2024, Dental Specialists of Minnesota, PLLC d/b/a The Dental Specialists filed a notice of data breach with the U.S. Department of Health and Human Services Office for Civil Rights after discovering that an unauthorized party was able to access an employee’s email account. In this notice, Dental Specialists explains that the incident…
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Artificial Intelligence & Product Liability
As federal agencies and states grapple with regulating artificial intelligence (AI) to enhance its safety profile, and as businesses race to adopt AI for myriad purposes, it is important to recognize a general safety framework already exists in the form of product liability laws. Notably, many industry experts have opined that AI systems are “black…
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What Is Polypharmacy And Why Should You Care?
Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts….By: Napoli Shkolnik
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Georgia’s Products Liability Statute of Repose: “First Sale” vs. “A Sale”
In L’Oreal USA, Inc. v. Burroughs, 372 Ga. App. 30, 2024 Ga. App. LEXIS 250, the Court of Appeals of Georgia (Appellate Court) considered whether Georgia’s ten-year statute of repose for products liability precluded strict liability and/or negligence claims where the product, allegedly causing injury, was first purchased more than 10 years ago, but new…
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Middle East Crisis: Israel and Hezbollah Exchange Strikes Amid Fears of Escalation
The Israeli military said it had hit weapons facilities, prompting Hezbollah to target an Israeli base, as tit-for-tat strikes continued across the Lebanese border.
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Russia Seeks to Turn Humbling Incursion Into Military Gains
Two weeks after Ukraine launched its surprise attack, Russian forces have recovered from the initial shock and are trying to use the expanding war to their battlefield advantage.
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China’s ‘Road Trip Auntie’ Is Ready for a New Milestone: Divorce
Su Min became an internet sensation for leaving behind an abusive husband to drive across China alone. Now she’s ending the marriage, but there will be a price.
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‘Keyboard Warriors’ Who Stoked UK Riots Test the Limits of Free Speech
As hundreds of people appear in court for their role in recent anti-immigrant riots in Britain, several are accused of fueling disorder through online posts, raising questions about the limits of free speech.
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Four Bodies From Bayesian Yacht Found in Sicily
The discoveries came after the vessel went down this week in what some witnesses described as a waterspout, or a small tornado, during a violent downpour. No names were immediately released.
