How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley +1 more source
Alcohol demand and alcohol use disorder among adolescents and young adults who drink heavily: An exploratory analysis including sex differences. [PDF]
Gex KS +7 more
europepmc +1 more source
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
Barriers to Childhood Immunisation in Selected Zero-Dose Communities in Gauteng Province: A Qualitative Study. [PDF]
Majola TN +10 more
europepmc +1 more source
Zuranolone: A case study in (regulatory) rush to judgement?
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove +4 more
wiley +1 more source
International medical graduates: a crisis of political choice. [PDF]
Abbasi K.
europepmc +1 more source
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari +2 more
wiley +1 more source
Unveiling healthcare disparities in Somalia: the hidden struggles of nomadic communities. [PDF]
Duale HA +5 more
europepmc +1 more source
Carbamazepine is licensed in the United Kingdom for the treatment of epilepsy, bipolar disorder and trigeminal neuralgia. The related compounds oxcarbazepine and eslicarbazepine are licensed for the treatment of epilepsy. These drugs can cause immune‐mediated hypersensitivity reactions, which typically affect the skin, and can be of variable severity ...
Lucy Galloway +24 more
wiley +1 more source
Feasibility of drone-based sputum sample and medicine transport for tuberculosis diagnosis in Yadadri-Bhuvanagiri District of Telangana, India: A qualitative study. [PDF]
Kamble BD +8 more
europepmc +1 more source

