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Cancer therapy has undergone a drastic revolution in the past few decades with the introduction of several novel therapies, like immunotherapy (active and passive), stem cell-based therapies, and nanocarrier-based therapies. These therapies have addressed the issues of conventional cancer therapy (chemotherapy or radiotherapy), like specificity and off-target effects. Further, the introduction of such treatments has improved survival and converted a terminal disease into a more manageable condition. However, many clinical, ethical, and regulatory issues are raised with such novel additions. Several effective therapies are under research but could not come to market or are delayed due to regulatory concerns for marketing approval. The scope of this review encompasses the examination of these regulatory issues and discuss their possible solutions. A practical and flexible regulatory approach, harmonized globally, could help the patients suffering from a terminal illness to lead a quality life. [ABSTRACT FROM AUTHOR]

Globally, transgenic or genetically modified (GM) crops are considered regulated products that are subject to regulatory oversight during trans-boundary movement, testing and environmental release. In Africa, regulations for transgenic crops are based on the outcomes of the historic Earth Summit Conference held in Rio, Brazil two decades ago, namely, the adoption of the Convention on Biological Diversity (CBD) and the subsequent adoption of the Cartagena Protocol on Biosafety. To exploit the potential benefits of transgenic crops while safeguarding the potential risks on human health and environment, most African countries have signed and ratified the CBD and the Cartagena Protocol on Biosafety. Consequently, these countries are required to take appropriate legal, administrative and other measures to ensure that the handling and utilization of living modified organisms are undertaken in a manner that reduces the risks to humans and the environment. These countries are also expected to provide regulatory oversight on transgenic crops through functional national biosafety frameworks (NBFs). While in principle this approach is ideal, NBFs in most African countries are steeped in a host of policy, legal and operational challenges that appear to be at cross-purposes with the noble efforts of seeking to access, test and deliver promising GM crops for use by resource-limited farmers in Africa. In this paper we discuss the regulatory challenges faced during the development and commercialization of GM crops based on experiences from countries in Sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

This article aims to address challenges of translating emerging scientific technologies into legal terms and incorporate them into the existing North American regulatory regimes. A lack of full scientific knowledge about nanomedicine technologies results in the lack of development in legal discourse to describe products and to clearly set legal standards on their safety and efficacy. The increasing complexity and hybrid nature of technologies negatively impact the functionality of 'law in action' leading to a legal uncertainty and ultimately to a public distrust. Nanomedicine is an illustrative example of how law lags behind increasingly fast-paced scientific technologies making it difficult to find a balance between innovation and safety. This article argues that the boundary crossing nature of nanomedicine through different domains of science triggers a methodological and epistemological debate within science and law, suggesting that a critical revision is required in our traditional methods to learn, create, and categorize knowledge from breakthrough scientific advances. The highly disruptive nature of nanomedicine places stress on traditional conceptual frameworks, classifications of knowledge, and existing regulations. The legal challenge to identify definitions or to classify nanoapplications brings to light a conceptual vacuum surrounding nanomedicine. Moving away from confusing policies and obsolete classificatory models, this article suggests to undertake changes that are only the first steps of a more in-depth 'epistemological transformation' that addresses knowledge as the process of not only gathering data, but also, as the process of elaborating new conceptual bases to better fulfill the legal language and facilitate the legal task of finding definitions and formulating criteria more adherent with scientific advances. This should compel regulators to explore new paradigms and develop new methodologies to evaluate data on nanomedicine applications in order to provide sustainable bases for a responsible development of nanomedicine. [ABSTRACT FROM AUTHOR]

Soft regulatory measures are often promoted as an alternative for existing regulatory regimes for nanotechnologies. The call for new regulatory approaches stems from several challenges that traditional approaches have difficulties dealing with. These challenges relate to general problems of governability, tensions between public interests, but also (and maybe particularly) to almost complete lack of certainty about the implications of nanotechnologies. At the same time, the field of nanotechnology can be characterized by a high level of diversity. In this paper, we discuss and compare two models for framing public policy in relation to technology regulation: the first is a deliberative model based on foresight knowledge and the second the wide reflective equilibrium model, developed by political philosopher John Rawls. In both models, the aim is to find consensus on (a framework for) policy measures and regulation. On the basis of a critical discussion of the strengths and weaknesses of both models, some tentative conclusions are drawn for effective policy making and implementation based on soft law. [ABSTRACT FROM AUTHOR]