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By Lynn L. Bergeson Two food-producing companies have jointly launched an initiative to drive the adoption of products and services on-farm at scale to increase sustainability on Earth. The initiative invites companies and entrepreneurs with new and emerging on-farm sustainability products and services, focused on greenhouse gases (GHG) reduction, to submit solutions to the leading companies’ experts. In August 2019, participants will be selected to present their solutions to an audience...

By Lynn L. Bergeson On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be...

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...

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,...

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...

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...

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...