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New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products. New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.

Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA regulations embody sufficient flexibility to accommodate the emerging tools and methods needed to achieve this goal. Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA regulations embody sufficient flexibility to accommodate the emerging tools and methods needed to achieve this goal.

Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that remain crucial to maintaining this momentum, such as the use of the totality of evidence in evaluating orphan drugs. Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that remain crucial to maintaining this momentum, such as the use of the totality of evidence in evaluating orphan drugs.

The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices. The term “real-world evidence” is widely used by those who develop medical products or who study, deliver, or pay for health care, but its specific meaning is elusive. We believe it refers to information on health care that is derived from multiple sources outside typical clinical research settings, including electronic health records (EHRs), claims and billing data, product and disease registries, and data gathered through personal devices and health applications. 1 , 2 Key to understanding the usefulness of real-world evidence is an appreciation of its potential for complementing the knowledge gained from traditional clinical trials, whose well-known limitations make it difficult . . .

Flexible factories and adaptive fabrication lines offer a testbed for advanced multimodal interaction concepts that can support the inclusion of disabled workers in Industry 5.0 manufacturing systems. The study synthesizes interdisciplinary data from ergonomics, industrial automation, and EU regulatory frameworks to establish a conceptual model for human-machine interaction. Building on conceptual modeling and a structured literature analysis, the study proposes a six-step integration framework that links task demands, worker capabilities, and interaction modalities within human-in-the-loop manufacturing environments. Although no empirical case study was conducted in this phase, an exemplary application is presented for a semi-automated bike wheel manufacturing process. Detailed machine-based assembly line flows and simulated process data were utilized for illustrative purposes to depict the process and validate the proposed Capability–Task Matching Matrix. The results operationalize the human-centric vision of Industry 5.0 by providing a structured methodology for the inclusion of disabled workers within fabrication environments. The findings are organized into two primary components: the conceptual development of the Integration Approach and its practical application to a semi-automated industrial use-case. Finally, a particular focus is placed on Brain–Computer Interfaces (BCIs) as an emerging interaction channel that enables non-muscular control, attention monitoring, and neuroadaptive feedback, complementing conventional interfaces rather than replacing them. The framework is illustrated through application to the same semi-automated bicycle wheel assembly line, where BCI-supported interaction, augmented interfaces, and robotic assistance are mapped to specific production tasks and assessed in terms of feasibility and technological maturity. Drawing on the paper’s results, an explanatory 10-year roadmap outlines the feasibility and phased deployment of BCI solutions. It aligns technological advances with European regulations and a vision for a fully inclusive manufacturing enterprise.

Development of the vertebrate central nervous system depends on the generation of specific neural cells in appropriate numbers at defined times. Towards understanding such developmental events, it is essential to link progenitor cell coordinate position and genetic profile in the embryo to a final fate in the adult. We develop and apply genetic fate mapping methodologies to examine progenitor-progeny cell relationships for the rhombic lip (RL)---a hindbrain germinal zone productive of essential neural cells in the brainstem, for which experimental study has been challenging given its deployment of progeny cells across complex, long-distances. We determine that the lower RL (LRL) is subdivided along its dorsoventral axis into molecularly-defined territories, each corresponding to a particular fate: Lmx1a/Gdf7 expression define the territory which produces the hindbrain roof plate epithelium (hRPe) and hindbrain choroid plexus epithelium (hCPe); Math1 defines the territory which produces the mossy fiber afferent system; and Ngn1 likely defines the primordium for a subset of climbing fiber precerebellar afferents. These findings, taken together with loss-of-function studies, support the model that specification events are enacted within the LRL. Cell types emerge from the LRL at distinct intervals of time; temporal specificity of gene expression represents a separate axis for fate regulation. To address how progeny cell types deploy from the RL over time, we develop and apply an inducible genetic fate mapping approach. Having identified that the Gdf7+/ Lmx1a+ subdomain within the RL harbors progenitors for both hRPe and hCPe, we study further the development of these organizing centers important for dorsal hindbrain patterning. It is unclear how they are related with respect to lineage and gene expression. We address how cells in the hRPe are organized and whether they contribute to the hCPe. We find that the hRPe is comprised of three distinguishable fields, each differing in tissue organization, proliferative state, order of emergence from the RL, and molecular profile---only two fields contribute to the hCPe. We determine that the RL produces hCPe cells directly until late in embryogenesis. We further determine that hindbrain cells in the Gdf7, but not Math1 lineage hyperproliferate in response to constitutively active Notch1.

B.C. Ombudsman Stephen Owen has argued that treatment of AIDS patients with AZT is similar to treating cancer patients with chemotherapy drugs (Ombudsman Urges B.C. To Cancel Charges For AIDS Drug - April 30). Unfortunately, Health Minister Peter Dueck has already indicated that the opinion of the Ombudsman is unlikely to influence government policy.

As one of the 2,000 cancer patients in British Columbia receiving free chemotherapy treatment, I ran easily imaging the additional psychological and financial strain if I were suddenly required to pay, even partly, for my treatment. Yet this additional burden has been...

Vancouver BC -- As a native British Columbian, I am indeed \"affronted and frightened\" by William Vander Zalm 's style of government (Government By Conviction - Feb. 13).

A dictionary of scientific terms will yield the meaning of \"fractal.\" One wonders, however, what the Esalen Institute means by the enticing phrase \"fractal time.\" Perhaps it intends...