The latest headlines across every section, pulled from official and open-access sources.
FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.
by Kira Elsbernd, Issa Sabi, Ilesh V. Jani, Chishamiso Mudenyanga, Siriel Boniface, Arlete Mahumane, Joaquim Lequechane, Falume Chale, Bindiya Meggi, Kassia Pereira, Raphael Edom, Anange F. Lwilla, W. Chris Buck, Nyanda Elias Ntinyinya, Michael Hoelscher, Till Baernighausen, Arne Kroidl, Stefan Kohler, the LIFE Study Consortium Background Timely access to early infant diagnosis (EID) is crucial for newborns with HIV, as late diagnosis can delay lifesaving antiretroviral treatment (ART). We assessed the comparative cost and cost-effectiveness of integrating point-of-care EID at birth into…
by Rami Subhi, Abiodun Sogbesan, Dan Muramuzi, Mikael Burhin, Ayobami A. Bakare, Adegoke G. Falade, Freddy E. Kitutu, Freddie Ssengooba, Carina King, Sumit Kane, Belinda Dawson-McClaren, Hamish R. Graham, the MOXY-Implementation Research Collaboration Background Child mortality remains high in countries with weak emergency care systems. Facility organisation for paediatric emergency care is heterogeneous and under-described. We examined how hospitals in Uganda and Nigeria are organised to deliver emergency care for neonates and children. Methods and findings We conducted a qualitative…
by Camila Bonfim, Flávia Alves, Maurício L. Barreto, Vikram Patel, Daiane Borges Machado Background Interpersonal violence is a significant public health issue, increasing mortality risks for those affected. While Cash Transfer Programs offer health benefits, their role in addressing the needs of interpersonal violence victims remains unclear. This study aims to examine the association between Brazil’s Bolsa Família Program (BFP) participation and reduced mortality rates among interpersonal violence victims. Methods and findings This cohort study was conducted using data from 100 Million…
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. — Thea Pharma, Inc. · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. — Thea Pharma, Inc. · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. — Alcon Research LLC · Class II · Ongoing
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. — Hikma Pharmaceuticals USA INC · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Lack of Assurance of Sterility — SCOPE HEALTH · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Failed PH Specifications — Water-Jel Technologies, LLC · Class III · Ongoing
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. — Alcon Research LLC · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Labeling: Missing Label — American Regent, Inc. · Class III · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.
by Yanshang Wang, Chang Cai, Zhenyu Shi, Qian Gao, Alex Bottle, Mansour Taghavi Azar Sharabiani, Joshua Stott, Benedict Hayhoe, Ping He Background The prevalence of physical, psychological, and cognitive multimorbidity is characterised by marked socioeconomic status (SES) inequalities. However, the relationships between multimorbidity patterns—particularly those involving cognitive conditions—and healthcare utilisation, as well as the role of health insurance, remain poorly understood. This study aims to explore healthcare-seeking behaviour among individuals with multimorbidity and assess…
Dr. Centor discusses advancing clinical mastery as a strategy to revitalize primary care practice with Dr. Richard Kravitz.
Hepatitis B virus (HBV) infection affects around 254 million people worldwide and causes more than 1 million deaths annually. Author Anna Lok, MD, from the University of Michigan discusses HBV transmission, screening, and treatment with JAMA Associate Editor Beverly Forsyth, MD. Related Content: Hepatitis B Hepatitis B Virus Treatment Gaps in the US Tenofovir and Hepatitis B Virus Transmission During Pregnancy US Newborn Hepatitis B Virus Vaccination Rates
NCI Director Dr. Anthony Letai shares his reflections on this year’s AACR Annual Meeting, including science that stood out and NCI’s leading priorities.