The latest headlines across every section, pulled from official and open-access sources.
This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a comprehensive list of all applicable statutory and regulatory requirements.
Introduction Blunt chest trauma is frequently associated with rib fractures, and inadequate pain control may lead to respiratory complications and prolonged ventilatory support. In spontaneously breathing patients, pain impairs coughing and secretion clearance, promoting atelectasis and respiratory failure, while in mechanically ventilated patients, it may delay weaning. Current French guidelines recommend intravenous multimodal analgesia as first-line therapy followed by thoracic epidural or paravertebral block if pain remains uncontrolled. However, these techniques have limited applicability…
The FDA is allowing MMI to enroll more patients in a feasibility trial studying use of the Symani robot for microsurgery to restore drainage paths in the lymph nodes of Alzheimer's patients.
Report bringing together data on the delivery of globally competitive clinical research through the UK Clinical Research Delivery programme.
The deal to provide a range of imaging and therapeutic technologies to Cleveland Clinic extends the partners’ longtime relationship and follows a recent 10-year pact between Siemens Healthineers and Mayo Clinic.
Caring for patients with ADHD, or those who potentially have ADHD, extends far beyond diagnosis and prescribing. The post The Battles We Face: ADHD From A Patient Perspective, And What Providers Should Know appeared first on MedCity News .
What healthcare needs now is a connected, deeply integrated system of action that works with the system of record to complete work across the enterprise, supported by accountable partners willing to stand behind the outcomes they create. The post Three Ways Distressed Healthcare Must Evolve appeared first on MedCity News .
Urgent work to take place to protect bereaved families.
After hospitalization for heart failure (HF), most new prescriptions for guideline-directed medical therapy (GDMT) went unfilled, and most newly initiated prescriptions did not persist to the six-month mark, according to a recent study published in JAMA Internal Medicine.
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
This guidance provides recommendations for the design and conduct of studies to evaluate the in 17 vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery 18 system (collectively referred to as TDS2).
Generics
Efficacy supplement (new or revised indication). solution, intravenous. Sponsor: Novartis
Minutes of a meeting held between the government, NHS England and ABPI about the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG).
Objectives Uncertainty is inherent within medicine. Evidence-based medicine (EBM) teaching within medical curricula seeks to prepare doctors to make clinical decisions within conditions of uncertainty. The goals and scope of training for medical students and doctors are defined by published EBM competencies. We conducted a scoping review to identify the aspects of clinical uncertainty that are addressed by EBM competencies. Design A scoping review was conducted to identify and synthesise existing literature and models of clinical uncertainty, with help from an advisory group. Reported…
Introduction Following the reclassification of COVID-19 as a category V infectious disease in Japan in May 2023, systematic public health monitoring of case numbers and cluster outbreaks was discontinued. Consequently, infection control measures, responses to cluster outbreaks and vaccination coverage in long-term care facilities were largely left to the discretion of individual facilities, and the understanding of the current situation in these settings remains insufficient. This observational study aims to retrospectively investigate COVID-19 cluster outbreaks and the resulting burdens…
Objective Artificial intelligence (AI) is beginning to be used within digital surgical wound monitoring to facilitate implementation at scale. AI acceptability is essential to its success. This study aimed to explore patient and staff acceptability of an AI-based digital surgical wound monitoring platform. Design Qualitative interviews Setting Two hospitals performing cardiac surgery in England. Participants 20 patients undergoing cardiac surgery and 10 clinical staff participating in a randomised feasibility trial of surgical wound monitoring with AI. Interventions Semi-structured interviews…
Objectives To investigate the impact of government health expenditure on health outcomes in China, including its direct effects, underlying pathways and how these effects vary under different conditions of expenditure scale, health resource availability and economic development. Design A quantitative study using provincial panel data from 2008 to 2023. Analysis was conducted using a fixed-effects model, with instrumental variables employed to address potential endogeneity. A mediation model was used to examine indirect pathways and a threshold regression model was applied to explore…
Study design Multicentre randomised controlled trial. Setting Eight spinal cord injury (SCI) centres and 15 rehabilitation centres in Germany. Objectives To demonstrate the superiority of neuromuscular feedback therapy using an exoskeleton compared to conventional therapy in terms of improving walking ability in patients with chronic SCI. Methods A total of 180 patients with chronic complete or incomplete SCI and residual motor function in the lower extremities are to be included. Baseline examination will be carried out at the recruiting SCI centres, followed by 1:1 randomisation at the…
Introduction Breast cancer survivors (BCS) often experience side effects such as the fatigue, sleep disturbance and depression symptom cluster (FSDSC). Previous studies have demonstrated the potential efficacy of Tai Chi (TC) for improving FSDSC in BCS in a hospital setting in China. This study will explore the feasibility, acceptability and preliminary effects of the Easy 8 Form TC protocol as an adjuvant therapy in BC survivorship care, adapted to a regional Australian community setting. Methods and analysis The purpose of the present study is to provide a codesigned TC protocol. This…
Objectives To explore organisational opportunities for person-centred care in residential aged care facilities from the perspectives of managers and staff. Design A qualitative study using focus group discussions and inductive thematic analysis followed by a deductive interpretation guided by a theoretical framework. Setting Residential aged care facilities providing long-term care for older people in Sweden. Participants A total of 23 participants were recruited using purposive sampling and participated in five focus groups. Participants included assistant nurses, occupational therapists…
Introduction Advanced practice nurses play a vital role in addressing the growing complexity of healthcare. Although well-established internationally, advanced practice nursing in Austria remains in its early stages. The University Hospital Salzburg introduced its first advanced practice nurses in 2017, and in 2020 launched a comprehensive initiative to develop and implement advanced practice nursing roles across multiple specialties. This initiative included role development based on international frameworks, the creation of an advanced practice nurse network, scientific mentoring and an…
Objectives To explore the existing artificial intelligence (AI) tools used in the assessment and management of dysphagia. Design Scoping review. Data sources MEDLINE (Ovid), Scopus, CINAHL (EBSCOhost), Cochrane Library, Joanna Briggs Institute (JBI) Evidence Synthesis, ProQuest and Google Scholar were searched for studies published between January 2000 and May 2025. Eligibility criteria Studies involving adults diagnosed with dysphagia that applied AI techniques for screening, diagnosis, prognosis or management were included. Non-human studies, paediatric-only studies, non-clinical simulations…
Introduction Physical inactivity is highly prevalent in older adults living in deprived communities, with many living with long-term health conditions. Community-based and tailored physical activity behaviour change programmes are needed to support increased physical activity in this population. This project aims to conduct a pragmatic pre-post mixed-methods evaluation of a community-based physical activity intervention (Move Together Buckinghamshire). Methods and analysis Move Together Buckinghamshire is a 3-year community-based physical activity programme for inactive adults aged over 50…