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Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled in United States v. Caronia that truthful off-label promotion was protected under the First Amendment, threatening government enforcement in this area.
The authors extracted cases from the WestLawNext database that mentioned Caronia from 2012 to 2019. They collected information about plaintiff, procedural history, product and manufacturer involved, and case outcome. Cases were categorized as either "follows," "does not follow," or "distinguishes" from Caronia. The authors qualitatively reviewed the full text of each case to verify whether Caronia was given substantive discussion for perceptions of off-label promotion, application of commercial speech rights, and how courts interpreted Caronia.
Among 42 cases in the study cohort, 22 (52%) followed Caronia's core holding that truthful, non-misleading off-label promotion was not actionable under FDA rules. By contrast, 20 cases (48%) treated Caronia negatively, either declining to follow (9 cases) or distinguishing it (11 cases).
Enforcement of restrictions on off-label marketing became more challenging after Caronia. This gives manufacturers greater flexibility to promote drugs for unapproved uses despite the substantial public health risks.
Enforcement of restrictions on off-label marketing became more challenging after Caronia. This gives manufacturers greater flexibility to promote drugs for unapproved uses despite the substantial public health risks.
Many recent advancements in single molecule localisation microscopy exploit the stochastic photo-switching of fluorophores to reveal complex cellular structures beyond the classical diffraction limit. However, this same stochasticity makes counting the number of molecules to high precision extremely challenging, preventing key insight into the cellular structures and processes under observation.
Modelling the photo-switching behaviour of a fluorophore as an unobserved continuous time Markov process transitioning between a single fluorescent and multiple dark states, and fully mitigating for missed blinks and false positives, we present a method for computing the exact probability distribution for the number of observed localisations from a single photo-switching fluorophore. This is then extended to provide the probability distribution for the number of localisations in a dSTORM experiment involving an arbitrary number of molecules. We demonstrate that when training data is available to estimate photoswitching rates, the unknown number of molecules can be accurately recovered from the posterior mode of the number of molecules given the number of localisations. Finally, we demonstrate the method on experimental data by quantifying the number of adapter protein Linker for Activation of T cells (LAT) on the cell surface of the T cell immunological synapse.
Software available at https//github.com/lp1611/mol_count_dstorm.
Supplementary data are available at Bioinformatics online.
Supplementary data are available at Bioinformatics online.
This article explains the policy process that occasioned the development of comprehensive tobacco control policies in Mauritius from 1980 to 2019. It does so by drawing theoretical insights from John Kingdon's streams framework, historical institutionalism, and ideational perspectives to explicate how tobacco control rose to the status of government policy agenda.
The main sources of data are government documents, media reports, archival studies, grey literature, and published books and articles. Ipatasertib in vitro These sources were supplemented by key informant interviews with government officials, civil society groups, and other vested interest groups.
This article finds that the prevalence of noncommunicable diseases in the late 1980s, the political commitment of Mauritius's Labour government to comprehensive tobacco control, the institutional legacies of Mauritius's Public Health Act of 1925, and the administrative capacity of Mauritius's Ministry of Health and Quality of Life are the primary factors that drove tobacco control policies in Mauritius.
The findings from this study will enrich our understanding of policy change and the politics of tobacco control in the global south. Future research should investigate why some countries in Africa have failed to adopt comprehensive tobacco control policies despite ratifying the Framework Convention on Tobacco Control.
The findings from this study will enrich our understanding of policy change and the politics of tobacco control in the global south. Future research should investigate why some countries in Africa have failed to adopt comprehensive tobacco control policies despite ratifying the Framework Convention on Tobacco Control.
The objectives and strategies used by an ambulatory care action team operating within a large health system's pharmacy incident command structure during the initial response to the coronavirus disease 2019 (COVID-19) pandemic are discussed.
In a time of crisis, a pharmacy ambulatory action team was formed to provide ambulatory clinical pharmacy expertise and meet an immediate and ongoing need to limit nonemergent care during the COVID-19 pandemic. By building a strong communication infrastructure and partnership with ambulatory care providers, clinic medical and operational leaderships, clinical laboratory staff, and infusion centers, the team was able to swiftly execute solutions and respond to new issues and requests. Ambulatory care pharmacy practice continued to advance through provision of services to vulnerable patient populations with chronic conditions that were anticipated to experience gaps in care management during the COVID-19 pandemic. These efforts resulted in expansion of pharmacists' involvement in collaborative drug therapy management, support of patients' transition from in-clinic injection to home self-administration, provision of medication assistance support, and management of 1,300 patients via protocol-based warfarin management. Additionally, ambulatory pharmacy services in 15 primary care, anticoagulation, and specialty clinic sites were transitioned to telehealth. The ambulatory action team also implemented several strategies to manage medication therapy associated with COVID-19-related shortages and implemented electronic decision support to guide prescribing of hydroxychloroquine and azithromycin.
Building a strong communication infrastructure and a pharmacy ambulatory action team were essential to respond to a crisis and continue ambulatory clinical pharmacy services expansion.
Building a strong communication infrastructure and a pharmacy ambulatory action team were essential to respond to a crisis and continue ambulatory clinical pharmacy services expansion.
Website: https://www.selleckchem.com/products/gdc-0068.html
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