Results 221 to 230 of about 664,139 (295)

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

From Criminal Liability to Patient Safety: The Possible Impact of the Italian 2025 Reform Proposal on Senior Healthcare Leadership and Clinical Risk Management. [PDF]

Healthcare (Basel)
La Micela S, Stevanin G, Pancheri A, Faes C, Bonetti A, Atti S, Tocco Tussardi I, Tardivo S.   +7 more
europepmc   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Excess Cockerels in the Context of Legal Regulations, Animal Welfare and the Bioeconomy. [PDF]

Animals (Basel)
Spasowska H, Ahsan U, Batkowska J.
europepmc   +1 more source

Awareness of the Black Triangle Scheme among healthcare professionals and consumers in Australia: A mixed‐methods study exploring reporting intentions and suggested improvements

British Journal of Clinical Pharmacology, EarlyView.
Aims The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements.
Eyob Alemayehu Gebreyohannes, Sieta T. de Vries, Mohammed Gebre Dedefo, Oliver Frank, Myra Thiessen, Lisa Kalisch Ellett, Christopher Thornton, Renly Lim   +7 more
wiley   +1 more source

COVID-19 legislative response and challenges in Republic of Korea. [PDF]

Front Public Health
Shin HY, Ki M.
europepmc   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Medicine quality in Somalia: Strengthening the pharmaceutical supply chain to protect patients. [PDF]

Prev Med Rep
Mohamed MA, Hassan AM.
europepmc   +1 more source