Tag Archives: Compliance

The Food and Drug Administration (FDA) has recently undertaken a significant reorganization of its Center for Devices and Radiological Health (CDRH) as a strategic move to fulfil its commitments under the Medical Device User Fee Amendments (MDUFA) V and to address the growing demands of modern healthcare technology. This restructuring involves vital changes in several […]

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Alzheimer’s disease, a neurodegenerative disorder, has been traditionally targeted through treatments focusing on the amyloid protein plaques in the brain, with recent drug approvals such as Eisai’s Leqembi and Eli Lilly’s Kisunla leading the way. These intravenously infused therapies use antibodies to break up amyloid proteins but come with risks such as bleeding and brain […]

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The U.S. House Appropriations Committee has requested that the Food and Drug Administration (FDA) halt its efforts to finalize regulations on laboratory developed tests (LDTs). This request was made in legislative proposals related to the funding of the FDA and other federal bodies for the fiscal year 2023. The committee, which passed the appropriations bill […]

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I apologize for any misunderstanding, but it seems like there was an error or a limitation in providing the full article text for review. The information you’ve provided is an introduction, likely to a full piece which discusses the updated FDA guidance on how life sciences companies can address misinformation about their products online. From […]

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In a recent announcement, the Food and Drug Administration (FDA) has raised concerns about disruptions in the supply of BD Bactec blood culture media bottles, highlighting potential impacts on patient diagnosis and subsequent management. Becton Dickinson (BD), the manufacturer of these bottles, acknowledged in June that its customers might face “intermittent delays” in receiving supplies […]

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Over the past two decades, the United States has witnessed a troubling trend in the closure of maternal care centers, predominantly in rural areas, leading to widespread maternal care deserts. Prior to these closures, 45% of rural counties lacked hospital maternity services, a situation that only worsened between 2004 and 2014 when an additional 9% […]

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The recent U.S. Supreme So the grid,options of your land’ looktureCourt decision to overturn the Chevron doctrine could have significant implications for the regulation of Food and Drug Administration (FDA) activities, particularly concerning lab-developed tests (LDTs). The 6-3 ruling in late June scrapped the Chevron deference, a legal principle that required courts to defer to […]

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Novo Nordisk recently faced a setback as the FDA rejected their application for icodec, a diabetes treatment designed for once-weekly dosing instead of daily injections. The FDA’s concerns centered on the manufacturing process and the drug’s application for type 1 diabetes, with specific worries about heightened risks of hypoglycemia. Despite this hitch, icodec continues to […]

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The Food and Drug Administration (FDA) has recently finalized guidance for medical device companies focusing on interventions designed to treat opioid use disorder (OUD). The guidance, which remains relatively consistent with the draft released in July 2024, addresses various clinical considerations for conducting studies and demonstrating the safety and effectiveness of such devices. Notably, no […]

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In a recent development, Johnson & Johnson (J&J) has restricted the use of three specific models of its Megadyne patient return electrodes, which are critical components used during electrosurgery. This decision follows reports that these devices pose a risk of causing burns to patients. In a June recall notice, J&J specified that these reusable electrodes—part […]

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