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Home » Topics » Regulatory

Regulatory
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Elderly woman holding illustration of brain with missing puzzle piece

Regulatory flexibility shown in cancer space needed in Alzheimer’s

June 14, 2024
By Mari Serebrov
Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
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Atkiia co-founders holding product box

Aktiia receives CE mark for calibration-free blood pressure system

June 14, 2024
By Shani Alexander
Aktiia SA recently received a CE mark for Calfree, its optical blood pressure monitoring technology that does not require calibration with a traditional cuff. The Calfree system can be integrated into a wide range of third-party devices, significantly improving hypertension management and as a result the quality of patients’ lives.
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Mifeprex

Supremes shoot down abortion pill challenge, raise new concern

June 13, 2024
By Mari Serebrov
The U.S. Supreme Court unanimously upheld the FDA’s relaxed regulation of the abortion drug mifepristone when it ruled June 13 that the organizations challenging those changes lacked the standing to do so.
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Biosecure Act misses first congressional ride

June 13, 2024
By Mari Serebrov
The Biosecure Act missed its first chance at a congressional ride June 11 when the U.S. House Rules Committee didn’t include it, as many had expected, on the list of potential riders the House will consider for its version of the National Defense Authorization Act, a must-pass defense spending bill for fiscal 2025. But that doesn’t mean the bill will be stranded by the wayside.
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U.S. Capitol building, Washington D.C.

US Congress revisits Medicare Advantage prior authorization

June 13, 2024
By Mark McCarty
The prior authorization practices of Medicare Advantage programs have drawn the ire of industry and physician societies alike recently, prompting the U.S. Centers for Medicare & Medicaid Services to open a request for information in January 2024. Congress seems poised to take matters into its own hands, however, with legislation that would force these plans to work to speed up these prior authorization processes, a bill that has the enthusiastic support of the Medical Device Manufacturers Association.
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digital health

Avicenna’s AI detection software cleared for vertebral compression fractures

June 13, 2024
By Shani Alexander
The U.S. FDA granted Avicenna.AI SAS 510(k) clearance for Cina-VCF, its artificial intelligence-based solution that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans. The company hopes that early detection of VCFs will allow patients to be checked for osteoporosis and start treatments early to reduce the risk of their fracture deteriorating.
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FDA Orange Book

US court adopts FTC stance in Orange Book listing challenge

June 12, 2024
By Mari Serebrov
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.
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Roches Cobas system and test

Roche gains US EUA for SARS-CoV-2, influenza, RSV molecular test

June 12, 2024
By Shani Alexander
The granting of emergency use authorization by the U.S. FDA to Roche AG for its four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and respiratory syncytial virus will allow the company to quickly bring the test to near-patient care environments ahead of the flu season, to address a real need in the marketplace, Ian Parfrement, head of the point of care customer area, at Roche Diagnostics, told BioWorld.
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DNA on digital background

US FDA jumps feet first into particulars of AI oversight

June 12, 2024
By Mark McCarty
The U.S. FDA is keen to develop tools for oversight of artificial intelligence (AI) as demonstrated by a batch of research projects designed to inform the review of medical applications of AI. The agency’s concern is that there is a dearth of “robust evaluation methods” for evaluating AI products, thus the need for tools that will allow the agency to clear or approve such products with an assurance that these algorithms are safe and effective for their intended use.
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Artificial intelligence and digital health icons

US NIH releases AI prognostic for response to cancer immunotherapy

June 12, 2024
By Mark McCarty
The U.S. National Institutes of Health has jumped into the artificial intelligence pool with a prognostic that predicts a patient’s response to immune checkpoint inhibitors as cancer therapies.
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