Food and Drug Administration (FDA) Research This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Reduction of product composition variability using pooled microbiome ecosystem therapy and consequence in two infectious murine models
In this study, we compared the metagenomic profile of pooled products to corresponding single donor-derived products. We demonstrated that pooled products are more homogeneous, diverse, and enriched in beneficial bacteria known to produce anti-inflammatory short chain fatty acids compared to single donor-derived products. We then evaluated pooled products' efficacy compared to corresponding single donor-derived products in Salmonella and C. difficile infectious mouse models. We were able to demonstrate that pooled products decreased pathogenicity by inducing a structural change in the intestinal microbiota composition. Sin...
Source: Cancer Control - April 23, 2024 Category: Cancer & Oncology Authors: Julie Reygner Johanne Delannoy Marie-Th érèse Barba-Goudiaby Cyrielle Gasc Beno ît Levast Enora Gaschet Laurent Ferraris St éphane Paul Nathalie Kapel Anne-Judith Waligora-Dupriet Frederic Barbut Muriel Thomas Carole Schwintner Bastien Laperrousaz Nat Source Type: research

Exploring the role of histone deacetylase and histone deacetylase inhibitors in the context of multiple myeloma: mechanisms, therapeutic implications, and future perspectives
AbstractHistone deacetylase inhibitors (HDACis) are a significant category of pharmaceuticals that have developed in the past two decades to treat multiple myeloma. Four drugs in this category have received approval from the U.S. Food and Drug Administration (FDA) for use: Panobinonstat (though canceled by the FDA in 2022), Vorinostat, Belinostat and Romidepsin. The efficacy of this group of drugs is attributed to the disruption of many processes involved in tumor growth through the inhibition of histone deacetylase, and this mode of action leads to significant anti-multiple myeloma (MM) activity. In MM, inhibition of hist...
Source: Experimental Hematology and Oncology - April 23, 2024 Category: Cancer & Oncology Source Type: research

Electronic cigarettes: beneficial for smoking cessation but harmful to public health?
This study is a step toward addressing that uncertainty about how e-cigarettes could be used to promote smoking cessation among... (Source: Emergency Medicine Journal)
Source: Emergency Medicine Journal - April 22, 2024 Category: Emergency Medicine Authors: Kruse, G., Samet, J., Barnoya, J. Tags: Press releases Commentary Source Type: research

Effect of Hepatic Impairment on Trilaciclib Pharmacokinetics
J Clin Pharmacol. 2024 Apr 19. doi: 10.1002/jcph.2435. Online ahead of print.ABSTRACTTrilaciclib is a first-in-class, intravenous cyclin-dependent kinase 4 and 6 inhibitor approved for reducing the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer receiving a platinum/etoposide-containing or topotecan-containing regimen. No dose adjustment is recommended for participants with mild hepatic impairment (HI) based on previous population pharmacokinetic (PK) analysis. This open-label, parallel-group study examined the impact of moderate and severe HI on the PK of tr...
Source: The Journal of Clinical Pharmacology - April 19, 2024 Category: Drugs & Pharmacology Authors: Chao Li Richard A Preston Emily Dumas Andrew Beelen Thomas C Marbury Source Type: research

Effect of Hepatic Impairment on Trilaciclib Pharmacokinetics
J Clin Pharmacol. 2024 Apr 19. doi: 10.1002/jcph.2435. Online ahead of print.ABSTRACTTrilaciclib is a first-in-class, intravenous cyclin-dependent kinase 4 and 6 inhibitor approved for reducing the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer receiving a platinum/etoposide-containing or topotecan-containing regimen. No dose adjustment is recommended for participants with mild hepatic impairment (HI) based on previous population pharmacokinetic (PK) analysis. This open-label, parallel-group study examined the impact of moderate and severe HI on the PK of tr...
Source: Clinical Lung Cancer - April 19, 2024 Category: Cancer & Oncology Authors: Chao Li Richard A Preston Emily Dumas Andrew Beelen Thomas C Marbury Source Type: research

Themes in e-liquid concept names as a marketing tactic: evidence from Premarket Tobacco Product Applications in the USA
Concept naming of flavours is popular among e-liquid manufacturers.1–3 Rather than explicitly stating a taste or smell, these names convey aesthetics or sensations (eg, unicorn, frostbite, roadhouse), as well as positive health and lifestyle experiences (eg, relaxed, blissful).4 Concept names are frequently accompanied by colourful packaging and bottle designs that reinforce their connotations.1 2 While concept naming is not novel, its impact on youth appeal, as distinct from the flavours themselves, is understudied.5 Concept naming warrants additional attention following US regulatory developments limiting character...
Source: Tobacco Control - April 19, 2024 Category: Respiratory Medicine Authors: Laestadius, L., Vassey, J., Kim, M., Ozga, J., Li, D., Stanton, C., Wipfli, H., Unger, J. B. Tags: Open access Industry watch Source Type: research

Evaluation and Modification of a Shared Decision-Making Tool for Peanut Allergy Management
This study refined the decision aid ’s content to better reflect patients’ and caregivers’ lived experience.Recent FindingsCurrent standard of care for peanut allergy is avoidance, although peanut oral immunotherapy has been approved by the Food and Drug Administration for use in patients 4 –17 years old.SummaryAn advisory board of allergy therapy experts (n = 3) and patient advocates (n = 3) informed modifications to the decision aid. The revised tool underwent cognitive debriefing interviews (CDIs) among adolescents (12–17 years old) with peanut allergy and caregivers of patients 4–17 years old with p...
Source: Current Allergy and Asthma Reports - April 19, 2024 Category: Allergy & Immunology Source Type: research

Establishing robust governance of clinical artificial intelligence software – Why radiologists should lead
The longstanding research and development of artificial intelligence (AI) within the field of Diagnostic Radiology and the larger medical universe has begun to translate into clinically useful tools. As of this publication, there are over 500 AI based radiology applications approved by the Food and Drug Administration (FDA) for commercial sale in the United States.1,2 Additional AI based non-clinical applications are marketed to improve workflow, patient follow-up, and other noninterpretable or nonpatient-facing tasks. (Source: Clinical Imaging)
Source: Clinical Imaging - April 19, 2024 Category: Radiology Authors: Joseph J. Cavallo, Melissa A. Davis Tags: Editorial Source Type: research

Use of the Pfizer Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp.PMID:38635488 | DOI:10.15585/mmwr.mm7315a4 (Source: MMWR Morb Mortal Wkl...)
Source: MMWR Morb Mortal Wkl... - April 18, 2024 Category: Epidemiology Authors: Jennifer P Collins Samuel J Crowe Ismael R Ortega-Sanchez Lynn Bahta Doug Campos-Outcalt Jamie Loehr Rebecca L Morgan Katherine A Poehling Lucy A McNamara Source Type: research

A critical review of the dextroamphetamine transdermal system for the treatment of ADHD in adults and pediatric patients
Expert Rev Neurother. 2024 May;24(5):457-464. doi: 10.1080/14737175.2024.2329306. Epub 2024 Mar 14.ABSTRACTINTRODUCTION: The dextroamphetamine transdermal system (d-ATS) is a stimulant patch recently approved by the United States (U.S.) Food and Drug Administration for the treatment of attention-deficit/hyperactivity disorder (ADHD).AREAS COVERED: The composition of the d-ATS, pharmacokinetics, and metabolism are presented along with data from dermal trials evaluating the tolerability of patch application at various skin sites. Efficacy and safety data from a laboratory classroom study in children and adolescents including...
Source: Expert Review of Neurotherapeutics - April 17, 2024 Category: Neurology Authors: Ann Childress Nicolas Vaughn Source Type: research

Overview of U.S. COVID-19 vaccine safety surveillance systems
This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccin...
Source: Vaccine - April 17, 2024 Category: Allergy & Immunology Authors: Julianne Gee Tom T Shimabukuro John R Su David Shay Margaret Ryan Sridhar V Basavaraju Karen R Broder Matthew Clark C Buddy Creech Francesca Cunningham Kristin Goddard Harrison Guy Kathryn M Edwards Richard Forshee Tanya Hamburger Anne M Hause Nicola P Kl Source Type: research