Low‐intervention clinical trials in Spain: Do they progress?
British Journal of Clinical Pharmacology, EarlyView.Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza +4 more
wiley +1 more source
Do world-wide policy initiatives for regulating health care related artificial intelligence safeguard the declaration of Helsinki? [PDF]
EClinicalMedicineArmoundas AA, Loscalzo J.
europepmc +1 more source
How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU
British Journal of Clinical Pharmacology, EarlyView.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
British Journal of Clinical Pharmacology, EarlyView.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
Violations of the right to food during deprivation of liberty: a global socio-legal assessment of United Nations Human Rights Treaty Bodies and the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment mission reporting on selected prisons since 2015. [PDF]
BMC Public HealthVan Hout MC +3 more
europepmc +1 more source
Zuranolone: A case study in (regulatory) rush to judgement?
British Journal of Clinical Pharmacology, EarlyView.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
Pandemic treaty textual analysis: ethics and public health implications. [PDF]
J Public Health (Oxf)Anderson EMR, Fenton E, Crump JA.
europepmc +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Aim The French authorities mandated the use of secure prescriptions for pregabalin on May 2021. This study aimed to evaluate the impact of this measure on pregabalin use and misuse in Nouvelle‐Aquitaine, a southwestern French region with around six million inhabitants.
Maika Munech‐Herran +5 more
wiley +1 more source
Devolution, National Pluralism and the Role of the UK Supreme Court. [PDF]
Oxf J Leg StudTirapu-Sanuy JM.
europepmc +1 more source
Mapping the research landscape of nanotechnology based immunotherapy for hepatocellular carcinoma. [PDF]
Discov OncolPeng B, Li R, Xu G, Gong L, Xiong L.
europepmc +1 more source