Results 191 to 200 of about 12,378,247 (300)
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
Working in Extreme Heat, an Invisible Occupational Risk: Legislation, Risk Management and Policy Recommendations for Türkiye: Turkish Thoracic Society Workshop Report on the Regulation of Working Conditions in Extreme Heat. [PDF]
Thorac Res PractGenç S +4 more
europepmc +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
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
Social goals and coping with interpersonal stress in adolescence. [PDF]
Front PsycholKuroda Y.
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 +4 more
wiley +1 more source
Impact of drug legislation on crime reduction: a systematic literature review. [PDF]
Front Public HealthTorres-Rodríguez MC +5 more
europepmc +1 more source
Proceedings of the ... congress of the International Association of Legislation (IAL)
, 2011 International Association of Legislation
core