In Reply We appreciate the Letter by Drs Leavens and Wagener in response to our Viewpoint that raised issues for the US Food and Drug Administration (FDA) to consider as it strives to regulate e-cigarettes.
Risultati per: FDA approva un nuovo trattamento per l’emicrania
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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.
Linee guida sul trattamento sistemico del cancro al seno metastatico
Revisione sull’uso degli anticoagulanti diretti come trattamento standard
Cardiopatia ischemica, un palloncino ne rivoluziona il trattamento
Tor Vergata è capofila come numero di interventi eseguiti
Emicrania, donne 3 volte più colpite, servono percorsi dedicati
Il 31 gennaio un incontro alla Camera per avanzare proposte
First At-Home Test for Chlamydia and Gonorrhea Receives FDA Approval
In 2021, the US saw an estimated 1.6 million chlamydia cases and more than 700 000 gonorrhea cases.
State-Regulated Psychedelics on a Collision Course With FDA
This Viewpoint examines how US states are reforming legislation to allow access to psychedelics for therapeutic use, but federal laws consider these agents to be Schedule I drugs, and the discordance between state and federal law may create confusion and conflict.
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.
Silencing the FDA’s Voice — Drug Information on Trial
New England Journal of Medicine, Ahead of Print.
Importante passo avanti per il trattamento dell’asma grave con benralizumab
Effetto dell’aspirina sul trattamento del cancro
Inequitable Conduct and Invalidation of Patents Related to FDA-Regulated Products
This study examines the frequency of drug patent invalidations based on inequitable conduct.
Analysis of Devices Authorized by the FDA as Clinical Decision Support in Critical Care
This case series study examines the clinical evidence cited for US Food and Drug Administration–approved clinical decision support devices for use in the critical care setting.
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.