Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes (...) oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight. (shrink)
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to (...) guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)
In two recent studies we have examined the prose rhythms in the clausulae of late imperial Latin authors. We found two clausular systems to be prevalent, the cursus and the cursus mixtus. The cursus involves the use of accentual rhythms and consists of three basic cadences: planus, tardus, and velox. The cursus mixtus has been defined by modern scholars as a type of prose rhythm in which the clausula is structured along both accentual and metrical lines, that is by the (...) combination of one of the three forms of the cursus with one of the standard metrical forms derived from Cicero's system — cretic-spondee, dicretic, cretic-tribrach, or ditrochee. (shrink)
The United Nations (UN) Universal Declaration of Human Rights engenders important state commitments to respect, fulfill, and protect a broad range of socio-economic rights. In 2010, a milestone was reached when the UN General Assembly recognized the human right to safe and clean drinking water and sanitation. However, water plays an important role in realizing other human rights such as the right to food and livelihoods, and in realizing the Convention on the Elimination of All Forms of Discrimination against Women. (...) These broader water-related rights have been recognized but have not yet been operationalized. This paper unravels these broader water-related rights in a more holistic interpretation of existing international human rights law. By focusing on an emerging approach to water services provision—known as ‘domestic-plus’ services—the paper argues how this approach operationalizes a comprehensive range of socio-economic rights in rural and peri-urban areas. Domestic-plus services provide water for domestic and productive uses around homesteads, which challenges the widespread practice in the public sector of planning and designing water infrastructure for a single-use. Evidence is presented to show that people in rural communities are already using their water supplies planned for domestic uses to support a wide range of productive activities. Domestic-plus services recognize and plan for these multiple-uses, while respecting the priority for clean and safe drinking water. The paper concludes that domestic-plus services operationalize the obligation to progressively fulfill a comprehensive range of indivisible socio-economic rights in rural and peri-urban areas. (shrink)
In several recent studies we have developed precise statistical methodologies which have demonstrated that the cursus mixtus was the dominant rhythmical system for final clausulae in Latin prose from the third century a.d. to the fifth. The cursus mixtus consisted of four standard metrical forms derived from the richer variety of Cicero's Asiatic tradition – cretic-spondee, dicretic, cretic-tribrach and ditrochee –, which were structured according to three accentual patterns – planus, tardus and velox. The latter are differentiated by the number (...) of unstressed syllables intervening between and following two accented syllables. The planus has two unaccented syllables between two word accents and one after the last accent. The tardus has two between two accents and two after the last accent. The velox has four between two accents and one after the last accent. The four metrical forms are contained within the parameters of the accentual cadences. The planus contains either the cretic-spondee or the ditrochee ; the tardus either the dicretic or the cretic-tribrach ; the velox either the ditrochee or the cretic-spondee (nimium videbatur. Authors who used the cursus mixtus, however, preferred to effect an exact coincidence between the accent and ictus, and as a result evinced primarily the following standard rhythmical forms: planus/cretic-spondee; tardus/dicretic or cretic-tribrach; and velox/ditrochee. So far now we have examined only the rhythmical properties of final clausulae, but it is appropriate also to investigate for rhythm at internal positions within the sentence. (shrink)