Results 91 to 100 of about 396,648 (275)

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
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, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Hidden behind a cloak of silence and exclusion: a qualitative study of healthcare professionals and mandated COVID-19 vaccinations

Kōtuitui
Aotearoa New Zealand (Aotearoa), like many countries, experienced widespread demand for health services, threatening to collapse the health system. In addition to stringent border control, isolation policies for those with COVID-19, and instituting ...
Jan Dewar, Te Wai Barbarich-Unasa, Gail Pacheco, Lisa Meehan, Denise Wilson   +4 more
doaj   +1 more source

The impact of medication shortages on paediatric care: A retrospective impact analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg, Laurens Christiaan van Rijn, Elisabeth Johanna Ruijgrok, Sinno Henricus Paulus Simons, Brigitta Carolina Maria Witjes, Jan‐Dietert Christoffer Brugma, Robert Bernard Flint   +6 more
wiley   +1 more source

Vaccine hesitancy and regulations in the United States: A Foucauldian Perspective

Journal of Public Health and Preventive Medicine
Vaccine hesitancy represents a critical barrier to equitable herd immunity, disproportionately affecting racial and socioeconomic minorities. This piece argues that state-imposed vaccine mandates reflect a paternalistic model of health governance that ...
Eashwar Krishna
doaj   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Demonstration of safety and enhanced seroprotection against hepatitis B with investigational HBsAg-1018 ISS vaccine compared to a licensed hepatitis B vaccine

, 2012
Adults 40 years of age and older have been shown to be hypo-responsive immunologically to the currently available hepatitis B virus (HBV) vaccines. Three intramuscular doses of a Toll-like receptor 9 agonist, 1018 immunostimulatory sequence (1018 ISS ...
안상훈
core  

Medicines, misinformation and machines: Navigating infodemics in the generative AI era

British Journal of Clinical Pharmacology, EarlyView.
Health information is now widely accessed through smartphones, online searches and increasingly through generative artificial intelligence (AI). These systems create new opportunities for communication, and in some routine contexts, well‐governed AI assistants could reduce exposure to lower quality sources by providing cautious, evidence‐aligned ...
Natansh D. Modi, Lisa M. Kalisch Ellett, Michael D. Wiese, Ashley M. Hopkins   +3 more
wiley   +1 more source

Insurance Mandates and Mammography [PDF]

Recently adopted federal health reform requires insurers to cover mammograms without cost-sharing. We examine similar state insurance mandates that vary substantially in the timing of adoption and in specifying the ages of women eligible for different ...
Christopher S. Carpenter, Marianne P. Bitler   +1 more
core  

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

Utilization of Infertility Treatments: The Effects of Insurance Mandates [PDF]

Over the last several decades, both delay of childbearing and fertility problems have become increasingly common among women in developed countries. At the same time, technological changes have made many more options available to individuals experiencing
Lucie Schmidt, Marianne P. Bitler
core