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
Decisions about risk taking: Elaborate dynamics between guests and hosts of peer-to-peer accommodation during COVID-19. [PDF]
Hu A, Pang J, Gan X.
europepmc +1 more source
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer +4 more
wiley +1 more source
The healthfulness of major food brands according to Health Canada's nutrient profile model for proposed restrictions on food marketing to children. [PDF]
Vergeer L +4 more
europepmc +1 more source
Listening to Hong Kong children's perspectives through pretend play
Abstract Quality in early childhood education and care (ECEC) has become an increasing concern in recent years. The issue has been regularly discussed by different stakeholders. However, the rising concern regarding quality in ECEC has not seriously taken into account children's perspectives.
Suzannie K. Y. Leung
wiley +1 more source
In vitro comparative quality evaluation of different brands of Amlodipine Tablets Commercially available in Jimma Town, South-western Ethiopia. [PDF]
Milkesa A +6 more
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
Relationship between Prices and Quality of Essential Medicines from Different Manufacturers Collected in Cameroon, the Democratic Republic of the Congo, and Nigeria. [PDF]
Gabel J +3 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
How TikTok Influencers Disclose Food and Beverage Brand Partnerships: Descriptive Study. [PDF]
Dupuis R +4 more
europepmc +1 more source

