Results 231 to 240 of about 463,663 (316)

The Climate Change and Health Working Group: Breaking Down Silos to Advance Health and Resiliency in Hawai'i. [PDF]

Hawaii J Health Soc Welf
Kiefer EM, McCallen J, Felton D, Camba MJ, Hagan K, Glauberman G.   +5 more
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

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

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

Challenges to Improving Health Care Delivery Through ERISA Fiduciary Litigation. [PDF]

J Law Med Ethics
Stein N, Hopkins E.
europepmc   +1 more source

Psychotropic medication use among community dwellers with and without Parkinson's disease – A nationwide cohort study

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims We studied the prevalence of psychotropic use and psychotropic polypharmacy in persons with Parkinson's disease (PD) during a 10‐year follow‐up, because longitudinal studies on this topic are scarce although non‐motor symptoms of PD are often treated with psychotropics.
Noora Nieminen, Anna‐Maija Tolppanen, Valtteri Kaasinen, Marjaana Koponen, Sirpa Hartikainen   +4 more
wiley   +1 more source

Assessing Compliance of Tobacco Advertisement Promotions and Sponsorship Ban in India: Challenges, Opportunities, and the Way Forward. [PDF]

Indian J Community Med
Khare R, Singh YP, Singh R, Wadhwa M, Chauhan G, Yadav A.   +5 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

Paradigm shifts in mental health legislation: a comparative analysis of WHO guidelines (2006 & 2023) and implications for future policies. [PDF]

Front Psychiatry
Xue Q, Chen B.
europepmc   +1 more source