Zuranolone: A case study in (regulatory) rush to judgement?
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
Non-governmental organisations and the regulation of harmful commodity industries: navigating global governance to change corporate practices. [PDF]
Lauber K +9 more
europepmc +1 more source
Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status
Abstract Background A rapid progress in the development of advanced therapy medicinal products (ATMPs) has taken place over the past decades. The ATMPs hold great potential but face challenges in the clinical development and the regulatory process.
Allan Cramer +4 more
wiley +1 more source
Reflections on Corporate Political Activity Taxonomies in the Context of Non-communicable Diseases and Mental Health Comment on "Corporate Political Activity: Taxonomies and Model of Corporate Influence on Public Policy". [PDF]
Collins T, Karapici A.
europepmc +1 more source
Abstract Quality in early childhood education and care (ECEC) is a contested concept and has generally been conceptualised by inter‐related indicators such as staff qualifications, educational environment, policy or child‐to‐staff ratios. There has been a more limited emphasis on how young children might perceive and experience quality.
Nikki Fairchild, Éva Mikuska
wiley +1 more source
Global disparities in the regulation of electronic cigarettes. [PDF]
Egbe CO, Nyatsanza S, Fagbule OF.
europepmc +1 more source
Reception Baseline Assessment and ‘small acts’ of micro‐resistance
Abstract In September 2021, following the global COVID‐19 pandemic, the Department for Education introduced a national standardised digital Reception Baseline Assessment (RBA) for all English 4‐year‐old children. We analyse RBA and its associated Quality Monitoring Visits, as a further intensification of the new public management of early years ...
Guy Roberts‐Holmes +2 more
wiley +1 more source
The Corporate Political Activity of the infant commercial milk formula industry in Mexico during the COVID-19 pandemic. [PDF]
Reséndiz-Lugo O +5 more
europepmc +1 more source
‘Where are the adults?’: Troubling child‐activism and children's political participation
Abstract Children's political participation is a well‐established theme in childhood studies. In this article we offer an original account of child activism that takes into account the entangled and emergent aspect of children as activists. We begin with a historical and a conceptual review, noting the importance of mid‐20th century developments such ...
Sharon Hunter, Claire Cassidy
wiley +1 more source
Ultra-processed foods and nutrition governance in Ecuador as a public health challenge. [PDF]
Mora-Domínguez J +2 more
europepmc +1 more source

