The latest headlines across every section, pulled from official and open-access sources.
Over-the-counter (OTC) or non-prescription drugs imported into the U.S. must comply with all the applicable requirements under the Federal, Food and Cosmetic Act (FD&C Act) and the pertinent regulations in Title 21 of the Code of Federal Regulations (21 CFR).
FDA verifies that drugs imported or offered for import into the U.S. meet federal law requirements at the time of import to protect patients and consumers.
Prescription drugs imported into the U.S. must comply with all the applicable requirements under the Federal, Food and Cosmetic Act (FD&C Act) and the pertinent regulations in Title 21 of the Code of Federal Regulations (21 CFR).
Once data starts moving across multiple systems, it becomes hard to track unless you’ve been very intentional about it from the start. The post Where Healthcare Data Systems Fail and How to Build Them Better appeared first on MedCity News .
The Plausible Mechanism Framework is a breakthrough. Turning it into treatments that reach families will take five things the framework doesn’t provide. The post The FDA Opened the Door For Rare Disease Patients — Here’s What It Takes to Walk Through It appeared first on MedCity News .
Drug Shortages: Additional News and Information
2026 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee
The healthcare affordability crisis in the U.S. has become a trust crisis, with a growing share of Americans walking away from care altogether. Industry leaders say the fix requires something the system has never really done: starting with the patient. The post Why One in Four Americans Is Walking Away from Healthcare appeared first on MedCity News .
The NRRW is a UK-based study and database established to monitor the health effects of long-term, low-dose occupational exposure to ionizing radiation.
Objectives Active learning strategies, including case-based learning (CBL), problem-based learning (PBL) and team-based learning (TBL), have been extensively studied in clinical and basic science education; however, their application in public health programmes remains under-explored. Public health professionals address population-level challenges that differ substantially from clinical practice, making it necessary to evaluate whether these pedagogies are effective in this field. This review examines how CBL, PBL and TBL have been used in public health education and what outcomes have been…
Introduction Loneliness and social isolation are critical public health issues linked to significant adverse health outcomes and increased healthcare utilisation, including visits to the emergency department (ED). The ED often serves as a primary societal safety net, providing care for vulnerable populations who may be disproportionately affected by these conditions. In fact, loneliness and social isolation might be the underlying reasons they presented to the ED in the first place either consciously or not. For such individuals, the ED encounter may represent a rare point of human contact…
Introduction Cardiovascular diseases (CVD) remain the leading cause of morbidity and mortality worldwide. Public health responses to CVD require complex, multisectoral strategies that combine population-wide preventive interventions with individualised approaches. Artificial intelligence (AI) and machine learning (ML) have emerged as transformative tools in this field, enabling more accurate diagnosis, prognosis and treatment personalisation. However, most AI applications remain confined to clinical domains, with limited translation into public health policy modelling. Objective This review…
Introduction Acute febrile illness is a major cause of morbidity and healthcare seeking in sub-Saharan Africa, including Mozambique. However, few studies have explored the perceptions and practices related to clinical management of acute febrile illness. Our aim was to understand the perceptions, knowledge and practices of healthcare professionals and community members regarding the management of acute febrile illness. Methods A qualitative study was conducted using a thematic analysis approach. Eight focus group discussions (FGDs) and three in-depth interviews (IDIs) were conducted in two…
Objectives This study aimed to explore the dual perspectives and challenges of clinical nursing educators and novice nurses regarding the implementation of nursing-specific mini-clinical evaluation exercise (mini-CEX) and direct observation of procedural skills (DOPS) in novice nurses’ training within a single tertiary hospital in China. Design A descriptive qualitative research design was used. Participants were selected using a purposive sampling method, and semistructured interviews were conducted to collect data, which were then analysed following the six-step thematic analysis process…
Objectives To examine whether exposure to anti-herpetic drugs (AHDs: acyclovir, valacyclovir, famciclovir) is associated with reduced risk of Alzheimer’s disease (AD) treatment initiation. Design Population-based retrospective matched cohort study. Setting University Groningen community pharmacy database IADB.nl, covering approximately 125 Dutch pharmacies (1994–2024). Participants 262 757 adults aged 50–80 years without prior dementia or AD treatment. Exposed individuals with antiherpetic prescriptions (n=23 887) were matched 1:10 to unexposed controls (n=238 870) by age, sex and calendar…
Objectives To develop predictive models for early and overall tuberculosis (TB) deaths for prospective use at TB diagnosis in resource-constrained TB programme settings. Design Statewide cohort study using routinely captured secondary data. Setting With the majority of TB deaths being early (within 2 months), India’s TB programme’s information management system ( Ni-kshay )-dependent death prediction models (using age, gender, TB site, previous treatment, microbiological confirmation, HIV, diabetes and bank account availability) are not feasible for prospective use, as few variables are…
Objectives To evaluate the feasibility, safety and acceptability of arm crank ergometry cardiopulmonary exercise testing (CPETarm) in patients with chronic limb threatening ischaemia (CLTI). Design Prospective feasibility single-arm cohort study. Setting A tertiary vascular surgery referral centre in Greater Manchester, UK. Participants Adult inpatients admitted with CLTI and scheduled for non-elective vascular intervention. Interventions Participants underwent bedside CPETarm using an incremental ramp protocol. Cardiopulmonary parameters measured included peak oxygen uptake, anaerobic…
Introduction After resuscitation from out of hospital cardiac arrest (OHCA), mechanical ventilation (MV) and respiratory management are fundamental to support patients in the intensive care unit (ICU) and to minimise secondary brain injury. Best practices for MV and association with clinical outcomes in patients with OHCA remain unclear. Methods and analysis This protocol describes a pre-planned respiratory-focused series of sub-analyses within the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, an ongoing interventional study evaluating 6-month…
Crisis preparedness and responseThe Management Board welcomed EMA’s support to African regulators in the context of the Ebola outbreak in the Democratic Republic of Congo and…
Dear Leaders of the G7, the G20, BRICS and of all nations, We write to you together, from Geneva and from Brasília, with one shared conviction: that the world must finish what it started, and that you can help it do so. We begin not with an institution or an annex, but with a memory the whole world shares. Not so long ago, our hospitals overflowed. Families said goodbye to the people they loved through glass, or by telephone, or not at all. Children lost grandparents. Doctors and nurses, exhausted beyond anything we had a right to ask of them, kept going anyway. Estimates from WHO and…
National influenza and COVID-19 report, monitoring COVID-19 activity, seasonal flu and other seasonal respiratory illnesses.
The Trump administration finalized a rule that embraces new types of Obamacare coverage, including 30% higher out-of-pocket costs for some plans, and a more novel approach that allows insurers to offer coverage without set networks of doctors and hospitals.
After congressional Republicans let expanded subsidies for Affordable Care Act plans expire at the end of last year, some families have decided the price is too great of a financial burden and canceled their coverage.
Why continuous audit readiness helps MedTech organizations move faster—without sacrificing confidence or control.