E-Cigarettes and FDA Nicotine Cap

To the Editor The proposal to cap nicotine concentrations in combustible cigarettes is based on sound scientific evidence that cigarettes with very low levels of nicotine will significantly reduce smoking- and tobacco-related harm. However, we believe that a proposal presented in a recent Viewpoint for a federal nicotine cap on e-cigarettes is misguided and runs contrary to current evidence. The focus on e-liquid nicotine concentrations alone is problematic because these restrictions fail to consider that e-cigarettes, unlike cigarettes, offer users ways beyond nicotine concentrations to control nicotine delivery, including manipulating device power and compensatory puffing. In fact, the best evidence suggests that this proposed policy would lead to a product that is as addictive as e-cigarettes with higher nicotine concentrations, which may be more appealing to young people, and more harmful.

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Gennaio 2024

FDA Approves First Chikungunya Vaccine

The US Food and Drug Administration (FDA) recently greenlit the first vaccine to prevent chikungunya, a disease spread by mosquitos carrying the chikungunya virus. The agency called the virus an “emerging global health threat” due to its growing prevalence and geographic range. The vaccine, marketed as Ixchiq by Valneva Austria GmbH, is approved for adults 18 years or older who are at high risk of exposure to chikungunya virus.

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Dicembre 2023

FDA Regulations of AI-Driven Clinical Decision Support Devices Fall Short

We are entering a new era of computerized clinical decision support (CDS) tools. Companies are increasingly using artificial intelligence and/or machine learning (AI/ML) to develop new CDS devices, which are defined by the US Food and Drug Administration (FDA) as software used in disease prevention, diagnosis, or treatment. Recognizing the potential implications for clinical practice, the 21st Century Cures Act enjoined the FDA to regulate these new devices.

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Dicembre 2023