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On December 5, 2019, the National Toxicology Program (NTP) announced that the NTP Technical Report on the Toxicity Studies of 1020 Long Multiwalled Carbon Nanotubes Administered by Inhalation to Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats and B6C3F1/N Mice is now available.  In 2003, the Rice University Center for Biological and Environmental Nanotechnology nominated nanoscale materials as a class of substances for toxicological evaluation.  The recommended...

On November 25, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the publication of a study published in Frontiers in Pharmacology entitled “Unpredictable Nanoparticle Retention in Commonly Used Plastic Syringes Introduces Dosage Uncertainties That May Compromise the Accuracy of Nanomedicine and Nanotoxicology Studies.”  The researchers in the study radiolabeled a variety of different nanoparticles, loaded suspensions of particles into different plastic...

By Lynn L. Bergeson On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 23, 2019, the Alliance to End Plastic Waste (AEPW) announced a partnership with innovation platform Plug and Play to develop an accelerator program focused on the plastics value chain to identify start-ups with innovative ideas addressing plastic waste. Named the End Plastic Waste Innovation Platform (EPWIP), this initiative will focus on solutions to lower the impact of plastic waste in the environment. Focus areas...

By Lynn L. Bergeson On October 25, 2019, Iowa State University’s (ISU) Vice President for Research, Dan Kirkpatrick, announced that Sundeep Vani, Ph.D., has joined the team as the Chief Technology Officer (CTO) for Biobased Products, a newly created role. Announced in an ISU press release, Dr. Vani’s role will be to serve as a conduit between research and industry. Dr. Vani will work closely with the Biobased Product platform leader, Brent Shanks, his team,...

On September 24 – 26, 2019, the European Commission’s (EC) Joint Research Center (JRC) hosted the 2019 Global Summit on Regulatory Science (GSRS19), which focused on nanotechnology and nanoplastics.  Co-organized with the Global Coalition for Regulatory Science Research, GSRS19 covered nanotechnology research and its role in enhancing regulatory decision making, including methods, standards, and applications.  In addition, GSRS19 also introduced methods and approaches to...

Registration has begun for the National Nanotechnology Initiative’s (NNI) November 12, 2019, webinar, “Global Harmonization of Nanoinformatics:  A Case Study in Convergence and Team Science.”  The webinar, part of NNI’s 2019 series on the environmental, health, and safety effects of nanomaterials (nanoEHS), “will share how engaged and collaborative communities in the United States, Europe, and elsewhere have provided an infrastructure capable of supporting sustainable design of...

The International Organization for Standardization (ISO) has published standard ISO/TS 21236-1:2019, “Nanotechnologies — Clay nanomaterials — Part 1:  Specification of characteristics and measurement methods for layered clay nanomaterials.”  The standard specifies characteristics to be measured of layered clay nanomaterials in powder form and chemically modified ones and describes their relevant measurement methods.  According to the standard abstract, there are...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on October 15, 2019, that it seeks topics that could be addressed in upcoming studies.  EUON conducts up to three studies annually that are intended to address knowledge gaps on nanomaterials that are of interest to the general public and the research community.  EUON states that it is looking for studies that address: According to EUON, the scope of the study can be on nanomaterials in general, a...

By Lynn L. Bergeson On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical...