Results 241 to 250 of about 77,958 (315)

Zuranolone: A case study in (regulatory) rush to judgement?

open access: yesBritish 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

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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

Listening to Hong Kong children's perspectives through pretend play

open access: yesBritish Educational Research Journal, EarlyView.
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

Reception Baseline Assessment and ‘small acts’ of micro‐resistance

open access: yesBritish Educational Research Journal, EarlyView.
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

‘Where are the adults?’: Troubling child‐activism and children's political participation

open access: yesBritish Educational Research Journal, EarlyView.
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

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