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
Black Youth and Caregiver Experiences of Racism in Pain Management: A Narrative Inquiry. [PDF]
Matthews B +4 more
europepmc +1 more source
Exploring new avenues: Psychedelic‐assisted therapy for young people
Rates of mental illness in young people are increasing, whereas the development of novel mental health treatments has not significantly progressed. Psychedelic‐assisted therapy, using substances such as psilocybin and 3,4‐methylenedioxymethamphetamine (MDMA), has shown potential in the treatment of mental illnesses in the adult population, including ...
Ioanna Artemis Vamvakopoulou +3 more
wiley +1 more source
Obstetric Violence Through the Perspectives of Women and Midwives in Hospital Birth Settings: A Qualitative Study. [PDF]
Yıldırım Varışoğlu Y +2 more
europepmc +1 more source
Evaluating a virtual paediatric adverse drug reaction clinic
Aims Adverse drug reactions (ADRs) are a common problem in paediatric health care. There is limited access to expertise in the evaluation and management of potential ADRs in children, limiting access to these services and creating delays in assessment and management.
Emily Hauck +2 more
wiley +1 more source
Living with coeliac disease in unsupportive systems: a qualitative study of women's free-text narratives. [PDF]
Rodríguez-Almagro J +5 more
europepmc +1 more source
This study provides the first open‐source tool to implement the complete TEN‐SPIDERS framework in linked datasets for the determination of the PDC for medication adherence. The TEN‐SPIDERS tool enables transparent, reproducible medication adherence research through automated reporting of all calculation parameters and flexible customization options ...
Adam C. Livori +8 more
wiley +1 more source
Quebec lung, liver and heart transplant recipients' perspectives on self-narratives and their experiences in creative writing workshops during the transplantation journey: a qualitative study. [PDF]
Ducharme L +10 more
europepmc +1 more source
Navigating ICU Survival With a Temporary Tracheostomy. A Phenomenological Hermeneutic Study. [PDF]
Akroute A +3 more
europepmc +1 more source
Regulatory harmonization: Evolution, globalization and future directions
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 +2 more
wiley +1 more source

