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How (not) to define 'assisted dying'.
J Med Ethics
January 2025
Anscombe Bioethics Centre, Oxford, UK
In the last 20 years 'assisted dying' (and/or its variants 'assisted death', 'assistance in dying', 'aid in dying') has become increasingly prevalent as a term to denote the intentional ending of the life of a patient by or with the assistance of a doctor. However, there is no agreed definition. This paper focuses on the debate over the definition of this term in the UK.
View Article and Find Full Text PDFLeveraging Model Master Files for Long-Acting Injectables.
Pharm Res
January 2025
Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, , MD, 20993, USA.
The U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a public workshop on May 2-3, 2024, titled "Considerations and Potential Regulatory Applications for a Model Master File (Lachaine et al Can J Psychiatry.
View Article and Find Full Text PDFUtilization of AF4 for characterizing complex nanomaterial drug products: Reexamining sample recovery and its impact on particle size distribution as a quality attribute.
J Chromatogr A
January 2025
Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA. Electronic address:
Asymmetrical flow field-flow fractionation (AF4) with multi-detection has continued to gain wider acceptance for characterizing complex drug products. An important quality attribute for these products is the measurement of the particle size distribution (PSD). Current limitations of established procedures (e.
View Article and Find Full Text PDFAntiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa.
Drug Saf
January 2025
Forum for Collaborative Research, University of California, Berkeley, Washington, DC, USA.
HIV-prevention efforts focusing on women of child-bearing potential are needed to end the HIV epidemic in the African region. The use of antiretroviral drugs as pre-exposure prophylaxis (PrEP) is a critical HIV prevention tool. However, safety data on new antiretrovirals during pregnancy are often limited because pregnant people are excluded from drug development studies.
View Article and Find Full Text PDFPharmacy Subscription Program and Medication Refills, Days' Supply, and Out-of-Pocket Costs.
JAMA Netw Open
January 2025
Amazon Health Services, Seattle, Washington.
Importance: Medication nonadherence imposes high morbidity, mortality, and costs but is challenging to address given its multiple causes. Subscription models are increasingly used in health care to encourage healthy behaviors; in January 2023, Amazon Pharmacy launched RxPass, a subscription program offering Amazon Prime members (hereafter, company members) in 45 states access to 60 common generic medications for a flat $5 monthly fee.
Objective: To evaluate the associations of program enrollment with medication refills, days' supply, and out-of-pocket costs.
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