Results 171 to 180 of about 6,073 (251)

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

Ideological positions in the chilean chamber of deputies (2002-2026): A legislative roll-call dataset. [PDF]

Data Brief
Fábrega J.
europepmc   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

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, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

Quantum technologies and geopolitics: comparing parliamentary rhetoric. [PDF]

EPJ Quantum Technol
Suter V, Pöhlmann G, Ma C, Meckel M.
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, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

A Mixed-Methods Study of Policymakers' Adoption of AI to Support Use of Research Evidence: Implications for Artificial Intelligence in Prevention Policy. [PDF]

Prev Sci
Crowley DM, Wright J, Winters A, Jones D, Pugel J, O'Neill P, Shaw B, Hamel S, Long E, Donovan M, Scott T.   +10 more
europepmc   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Generation and Translation of Nursing Science Research Interest and Implementation Group. [PDF]

Res Nurs Health
Booth AT, Ramick A, Harrison A, Owens S, Adebayo M, Arnold J, Fowler SB.   +6 more
europepmc   +1 more source

Awareness of the Black Triangle Scheme among healthcare professionals and consumers in Australia: A mixed‐methods study exploring reporting intentions and suggested improvements

British Journal of Clinical Pharmacology, EarlyView.
Aims The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements.
Eyob Alemayehu Gebreyohannes, Sieta T. de Vries, Mohammed Gebre Dedefo, Oliver Frank, Myra Thiessen, Lisa Kalisch Ellett, Christopher Thornton, Renly Lim   +7 more
wiley   +1 more source