Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
Impacts of Food Adulteration and Contamination: Health, Socio-Economic, and Legislative Aspects. [PDF]
Momtaz M, Bubli SY, Khan MS.
europepmc +1 more source
Zuranolone: A case study in (regulatory) rush to judgement?
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 +4 more
wiley +1 more source
Makeen Document Control System: Development, Standards-Based Validation, and Early Multisite Implementation of a Saudi-Built Laboratory Document Control Platform. [PDF]
Zamir K +4 more
europepmc +1 more source
Regulatory harmonization: Evolution, globalization and future directions
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 +2 more
wiley +1 more source
Ethical Priorities Among Commercial Genomics Professionals : Survey Evidence Highlighting Diversity, Fragmented Privacy Law, and Human Rights Risks as Central Participant Concerns. [PDF]
Walker A.
europepmc +1 more source
Towards appropriate guidance for the ethical challenges of environmentally sustainable prescribing
The environmental impact of medicines poses a significant threat to planetary and public health, making it essential to integrate environmental sustainability into prescribing practices. While the most effective measures to reduce environmental impact, such as reducing unnecessary prescriptions and medication waste, are consistent with appropriate ...
Joost D. Piët +22 more
wiley +1 more source
How Often Do Pharmacists End up in Court? Analysis of Civil and Criminal Case Law in Poland. [PDF]
Merks P +8 more
europepmc +1 more source
Abstract There is much interest in the potential for an alternative funding system for higher education students in England to support the spiritual and worldly needs of British Muslim students. At the heart of this issue lies a tension over whether the student financing system in English HE is haram, or forbidden under Islamic (Shari'ah) law, because ...
Richard Hall +2 more
wiley +1 more source
Simulation study on matrix acidification of heterogeneous reservoirs based on seepage-acid etching coupled discrete virtual internal bond. [PDF]
Yan Y, Wang Y, An N.
europepmc +1 more source

