By Lynn L. Bergeson From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of...
Category: Research and Testing
The International Organization for Standardization (ISO) has published standard ISO/TS 21361:2019, “Nanotechnologies — Method to quantify air concentrations of carbon black and amorphous silica in the nanoparticle size range in a mixed dust manufacturing environment.” The standard provides guidelines to quantify and identify particles of carbon black and/or amorphous silica in air samples collected in a mixed dust industrial manufacturing environment. The guidelines describe air sample...
On May 16, 2019, the American Chemical Society (ACS) will hold a webinar on working safely with nanomaterials in the laboratory. Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH), will moderate a panel including: The panel will discuss the importance of managing products containing nanomaterials by integrating them into an existing lab safety program. During this free interactive broadcast, they...
By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...
April 5, 2019
EPA Releases Draft Guidance For Pesticide Registrants On Plant Regulator Label Claims, Including Pla
By Lynn L. Bergeson On March 25, 2019, the U.S. Environmental Protection Agency (EPA) finally weighed-in on the murky and often misunderstood topic of label claims for plant regulators and plant biostimulants in posting its Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. EPA states that the draft guidance, issued...
March 28, 2019
ISO Publishes Standard on Matrix of Properties and Measurement Techniques for Graphene and Related 2D Materials
The International Organization for Standardization (ISO) has published standard ISO/TR 19733:2019, “Nanotechnologies — Matrix of properties and measurement techniques for graphene and related two-dimensional (2D) materials.” ISO states that since graphene was discovered in 2004, it has become one of the most attractive materials in application research and device industry due to its supreme material properties such as mechanical strength, stiffness and elasticity, high electrical and...
March 25, 2019
Registration Begins for NNI Webinar on Characterization and Quantification of Engineered Nanomaterials
Registration is available for the National Nanotechnology Initiative’s (NNI) April 9, 2019, webinar on “Characterization and Quantification of Engineered Nanomaterials: Drivers of NanoEHS Research.” The speaker will be Dr. Robert MacCuspie, Natural Immunogenics Corp., and Dr. Debra Kaiser, National Institute of Standards and Technology, will moderate. The webinar will examine the significant progress in characterization and measurement of engineered...
The U.S. Consumer Product Safety Commission (CPSC) published a March 19, 2019, Federal Register notice announcing that it will hold a public hearing on May 1, 2019, to receive views from all interested parties about the CPSC’s agenda and priorities for fiscal years (FY) 2020, which begins on October 1, 2019, and 2021, which begins on October 1, 2020. CPSC seeks comment on the following questions: CPSC’s 2018-2022 Strategic Plan notes that CPSC...
By Lynn L. Bergeson On, March 12, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) announced the publication of two draft documents related to the potential deregulation of a soybean variety GE for increased yield and resistance to the herbicide glufosinate. The draft documents are Draft Plant Pest Risk Assessment (PPRA) and Draft Environmental Assessment (dEA) for Petition to Deregulate GE Soybean for Increased Yield and Herbicide Resistance. The PPRA will examine any...
March 13, 2019
2019 NanoEHS CORs Workshop Will Be Held in October
The 2019 U.S.-European Union (EU) NanoEHS Communities of Research (COR) Workshop will take place October 15-16, 2019, at the Europole de l’Arbois in Aix en Provence, France. The workshop is organized by the U.S. National Nanotechnology Initiative (NNI) and the European Commission (EC). The agenda for the October 2018 Bridging NanoEHS Research Efforts Joint Workshop and the following presentations are available:...