The growing application of nanomaterials in healthcare products (i.e., cosmetics, medical devices, and medicinal products) has encouraged the upgrade of the regulatory framework within the European Community to better control their use and manage the risk of negative effects on human health and environment. Unfortunately, despite the efforts of European Authorities, the current legislation is still stratified and several criticisms remain because of the lack of well-established scientific knowledge on nanomaterials. Although the regulatory framework for cosmetic products is almost complete, the efficacy and/or safety assessment of nanomaterials in medicinal products and medical devices is still based on case-by-case evaluation because of the complexity of such systems.
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http://dx.doi.org/10.1016/j.drudis.2017.01.016 | DOI Listing |
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance lysate of C2c Maky and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of lysate of C2c Maky as a fungicide against downy mildew () on grapevines and table grapes.
View Article and Find Full Text PDFThe conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Spain and co-rapporteur Member State Germany for the pesticide active substance phosphine are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of phosphine as a post-harvest indoor insecticide to control insects infesting stored grains (barley, oat, rye, wheat), cacao and coffee beans, tree nuts and oilseeds and dried fruit via gassing application (gas-tight rooms/container).
View Article and Find Full Text PDFALTEX
January 2025
National Institutes of Health, National Institute for Environmental Health Sciences, DTT/NICEATM, Durham, NC, USA.
The integration of artificial intelligence (AI) into new approach methods (NAMs) for toxicology rep-resents a paradigm shift in chemical safety assessment. Harnessing AI appropriately has enormous potential to streamline validation efforts. This review explores the challenges, opportunities, and future directions for validating AI-based NAMs, highlighting their transformative potential while acknowledging the complexities involved in their implementation and acceptance.
View Article and Find Full Text PDFBone Res
January 2025
Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Erlangen, Germany.
Osteocytes are the main cells in mineralized bone tissue. Elevated osteocyte apoptosis has been observed in lytic bone lesions of patients with multiple myeloma. However, their precise contribution to bone metastasis remains unclear.
View Article and Find Full Text PDFJ Nucl Med Technol
January 2025
Charles Sturt University, Wagga Wagga, New South Wales, Australia.
The recent emergence of text-to-image generative artificial intelligence (AI) diffusion models such as DALL-E, Firefly, Stable Diffusion, and Midjourney has been touted with popular hype about the transformative potential in health care. This hype-driven, rapid assimilation comes with few professional guidelines and without regulatory oversight. Despite documented limitations, text-to-image generative AI creations have permeated nuclear medicine and medical imaging.
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