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FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023
On May 22, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) issued an untitled letter to AT Venture Center for Global Techtrepeneurship, LLC dba Regenerelle, LLC (Regenerelle) for marketing human cells, tissues, or cellular or tissue-based products (HCT/Ps) and exosomes without FDA premarket review……By: Sheppard Mullin…
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Regulation of AI Systems is Already Here – Look to Data Protection Laws
As the scramble continues to reckon with the rapid advancement of generative artificial intelligence models like ChatGPT, Bard, DALL-E, and MidJourney, and the promise of other AI and machine learning systems (for simplicity, “AI systems”) to come, legal and business professionals across industries are asking whether these systems will be regulated, and if so, how….By:…
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Pioneering Crypto Regulation: The Draft Proposal from Agriculture and Financial Services Chairs
The Republican heads of two significant House committees, Patrick McHenry of the House Financial Services Committee and Glenn Thompson of the House Agriculture Committee, have disseminated a preliminary bill. This bill introduces a legal mechanism for digital assets, starting as securities, to transition into being regulated as commodities….By: Montague Law
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FTC Commercial Data Surveillance Crack Down: Kochava Gains a Win in Data Privacy Suit
On May 4, 2023, an Idaho federal judge ruled that the Federal Trade Commission (FTC) needs stronger assertions of consumer harm in order for its data privacy suit against data broker/mobile analytics provider Kochava Inc. (“Kochava”) to proceed. The court simultaneously found no basis for Kochava’s suit to block the FTC’s enforcement action….By: Akin Gump…
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American College of Rehabilitation Medicine updates its 1993 Definition of Mild Traumatic Brain Injury
As reflected in the posts on this blog over the last several years, scientific understanding of “mild traumatic brain injury” (Mtbi) – often referred to as “concussion” – has advanced considerably over the last 30 years. Unfortunately many physicians, including those on the “front lines” for these injuries–in emergency rooms and primary care clinics–have not…
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Studies Find Overactive Bladder Medication Ditropan May Increase Risk of Dementia
A patient’s decision to take any prescription medication is a very personal one that requires the patient to weigh several variables, including the potential benefit the medication could provide as well as the possible risks. Most patients rely heavily on their doctor’s input, who, understandably, rely on information provided by the drug’s manufacturer….By: Console and…
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In New Ukrainian Attacks, U.S. Officials See Signs of a Counteroffensive
Kyiv has not formally announced the start of operations. But Russia said that major Ukrainian attacks had begun in the Donetsk region and that it had repelled the assaults and inflicted casualties.
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Nazi Symbols on Ukraine’s Front Lines Highlight Thorny Issues of History
Troops’ use of patches bearing Nazi emblems risks fueling Russian propaganda and spreading imagery that the West has spent a half-century trying to eliminate.
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Oxford Business College and Others Make Millions Off Immigrant Students
Oxford Business College and others like it make millions, largely by recruiting immigrants. They operate in an opaque corner of the British education system.
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As Assad’s Isolation Lifts, Syrian Refugees Fear Pressure to Return Home
Arab countries re-establishing diplomatic ties with Syria are making repatriation of Syrian refugees a top priority. “Even if they shoot me, I won’t go back,” a refugee in Lebanon said.
