This paper emphasises the importance of - and the complexity inherent in - the navigation of regulatory oversight and legal requirements in the area of electric utility performance. With a particular focus on utility companies in New York State, it discusses recent measures taken to adapt to the changing demands of regulatory compliance.
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Stipulations of cell and gene therapy and the ties to biomanufacturing.
Biotechnol Prog
January 2025
Department of Life Sciences, Albany College of Pharmacy and Health Sciences, Albany, New York, USA.
Cell and gene therapy (CGT) products are emerging and innovative biopharmaceuticals that hold promise for treating diseases that are otherwise beyond the scope of conventional medicines. The evolution of CGT from a research idea to a promising therapeutic product is due to the complementary advancements across various scientific disciplines. First, the innovations and advancements in gene editing and delivery technology have provided fundamental tools to manipulate genes and cells for therapeutic pursuits.
View Article and Find Full Text PDFEconomic and equity evaluation of age restrictions on over-the-counter diet pills and muscle-building supplements.
Health Aff Sch
January 2025
Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA 02115, United States.
Over-the-counter diet pills and muscle-building supplements are linked to increased eating disorder diagnoses, especially among youth. With limited regulatory oversight, minors may unknowingly consume harmful substances leading to other adverse effects. Massachusetts has proposed restricting sales to individuals under 18 years.
View Article and Find Full Text PDFGaps in the ethical governance of pharmaceutical clinical trials in Europe.
Front Med (Lausanne)
January 2025
Gispen4Regulatory Science Consultancy, Bilthoven, Netherlands.
The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key deficiencies: (1) European regulations only partially address ethical imperatives set by international guidelines, thereby restricting the ethical mandate of relevant entities; (2) the role of research ethics committees is largely limited to pre-approval activities, reducing continuous oversight during trials; (3) GCP inspectors operate within a narrow scope regarding ethical oversight, which limits their ability to identify a broad range of unethical practices; (4) there is insufficient transparency and collaboration between RECs and regulators, specifically GCP inspectorates, leading to fragmented oversight; and (5) there is minimal integration of ethical findings into the marketing authorization decision process by entities such as clinical assessors and the CHMP.
View Article and Find Full Text PDFGenomic insights support the taxonomic differentiation of Orla-Jensen 1919 (Approved Lists 1980) and Andrewes and Horder 1906 (Approved Lists 1980) as individual species.
Int J Syst Evol Microbiol
January 2025
China National Research Institute of Food & Fermentation Industries, China Center of Industrial Culture Collection, Beijing 100015, PR China.
is widely used as a starter culture in the production of cheese, yoghurt and various cultured dairy products, which holds considerable significance in both research and practical applications within the food industry. Throughout history, the taxonomy of has undergone several adjustments and revisions. In 1984, based on the result of DNA-DNA hybridization, was reclassified as subsp.
View Article and Find Full Text PDFMedical students' attitudes toward AI in education: perception, effectiveness, and its credibility.
BMC Med Educ
January 2025
NUST School of Health Sciences, National University of Sciences and Technology (NUST), Sector, Islamabad, H-12, 44000, Pakistan.
Background: The rapid advancement of artificial intelligence (AI) has revolutionized both medical education and healthcare by delivering innovative tools that enhance learning and improve overall outcomes. The study aimed to assess students' perceptions regarding the credibility and effectiveness of AI as a learning tool and to explore the dynamics of integrating AI in medical education.
Methodology: A cross-sectional study was carried out across medical colleges in Pakistan.
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