Results 181 to 190 of about 9,594,514 (288)

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

Reconceiving orphan drug market exclusivity as a conditional public-law entitlement: a sustainable regulatory governance model with comparative lessons for China. [PDF]

Front Med (Lausanne)
Quan G, Zhou Y, Liu Y, Wu Y, Yan Y.
europepmc   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

What patients value in data reuse for oncology research: a multi-stakeholder qualitative study to inform the European Health Data Space implementation in Belgium and beyond. [PDF]

Arch Public Health
Lalova-Spinks T, van Zeeland I, Léonard S, Horicks F, Taels B, de la Cruz PC, Bax L, Carton B, Dirkx W, Shabani M.   +9 more
europepmc   +1 more source

Towards appropriate guidance for the ethical challenges of environmentally sustainable prescribing

British Journal of Clinical Pharmacology, EarlyView.
The environmental impact of medicines poses a significant threat to planetary and public health, making it essential to integrate environmental sustainability into prescribing practices. While the most effective measures to reduce environmental impact, such as reducing unnecessary prescriptions and medication waste, are consistent with appropriate ...
Joost D. Piët, Steven R. Kraaijeveld, Erik M. Donker, Milan C. Richir, Caroline T. A. Moermond, Amy Booth, SanYuMay Tun, Thijs H. Oude Munnink, Patricia M. L. A. van den Bemt, Lorena Dima, Ben J. A. Janssen, Mathilde Jalving, Tomás Mauro van Emden, Fabrizio de Ponti, Robert Likic, João Costa, Marc Labriffe, Charlotte L. Bekker, Carlotta Lunghi, Elisabetta Poluzzi, Michiel A. van Agtmael, Yolande Voskes, Jelle Tichelaar   +22 more
wiley   +1 more source

Decapod Crustaceans in Animal Welfare Law: Fragmentation, Gaps, and Emerging Models in Europe and Oceania. [PDF]

Animals (Basel)
Fruscella L, Sicuso DA, Vitale D, Passantino A.   +3 more
europepmc   +1 more source

The impact of the current student loans regime on Muslim student engagement and retention in English higher education

British Educational Research Journal, EarlyView.
Abstract There is much interest in the potential for an alternative funding system for higher education students in England to support the spiritual and worldly needs of British Muslim students. At the heart of this issue lies a tension over whether the student financing system in English HE is haram, or forbidden under Islamic (Shari'ah) law, because ...
Richard Hall, Yusraa Maryam, Sumeya Loonat   +2 more
wiley   +1 more source

Balancing Scientific and Commercial Interests: The European Health Data Space Response to Commercial Scientific Research. [PDF]

Inquiry
Yao X, Sun Z, Man H.
europepmc   +1 more source

‘School is their whole world’: Teachers' perspectives on loneliness among children and adolescents from England and mainland China

British Educational Research Journal, EarlyView.
Abstract As front‐line observers and active participants in pupils' daily lives, teachers closely monitor pupils' social interactions, emotional states and behavioural changes. Their unique perspective enables them to detect problems in the social lives of their pupils that may not be immediately visible to peers, parents or mental health professionals.
Yixuan Zheng, Charlotte Bagnall, Caroline Bond, Elizabeth Birchinall, Pamela Qualter   +4 more
wiley   +1 more source

From prototype to deployment: An EU-centric lifecycle framework for law enforcement AI. [PDF]

Open Res Eur
Aramburu M, García J, Gaines S, Touleimat N, La Mattina E, Akhgar B, Kavallieros D.   +6 more
europepmc   +1 more source