By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. DOE EERE announced on March 22, 2021, awards totaling $27.5 million for 16 water infrastructure and treatment projects. Spanning 13 states, each project will focus on bringing new water and wastewater-treatment technologies from the applied R&D stage into the market. According to DOE, increasing numbers of utilities responsible for clean water have shifted from strict wastewater treatment models to a broader model of...
Category: FDA
The Society of Toxicology (SOT) in conjunction with the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide a colloquia series on Emerging Toxicological Science: Challenges in Food and Ingredient Safety. The colloquia will present scientific information that is high-quality, cutting-edge, future-oriented toxicological science and is intended to provide a well-grounded foundation to inform the work of FDA...
March 17, 2021
Lynn L. Bergeson, “The importance of regulatory diligence in funding,” Financier Worldwide, April 2021.
Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses. Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know...
Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to the...
On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval. The draft guide will be “the official compliance guide for imported...
November 12, 2020
Explanatory Statement for EPA Appropriations Bill Directs EPA Administrator to Involve FDA in NanoEHS Research
On November 10, 2020, the Senate Committee on Appropriations released 12 fiscal year (FY) 2021 appropriations bills and explanatory statements. The bill for the Department of the Interior, environment, and related agencies includes funding for the U.S. Environmental Protection Agency (EPA). The explanatory statement for the bill includes language regarding nanomaterials research at EPA and states: The Committee notes the increased capabilities that the Food and...
November 6, 2020
FDA Requests Comments On Reauthorization Of BsUFA
By Lynn L. Bergeson On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to...
October 22, 2020
EPA Provides Expedited Pathway for Companies to Claim “Long-Lasting” Efficacy for Antiviral Products
On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that is intended to help companies demonstrate to EPA that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19. EPA has not before now provided guidance on how stakeholders can demonstrate to EPA’s satisfaction that their product remains efficacious for periods of time given...
October 16, 2020
California to Consider Prop 65 Listing for Glyphosate, Neonicotinoids, and Other Substances
On October 6, 2020, the California Developmental and Reproductive Toxicant Identification Committee (DARTIC) announced it will be meeting on December 11, 2020, to discuss the possible developmental and reproductive toxicity (DART) of 22 chemical substances and chemical groups, including glyphosate and its salts, and three neonicotinoid pesticides (acetamiprid, clothianidin, and imidacloprid). DARTIC is composed of scientists who advise California’s Office of Environmental Health...
October 6, 2020
FDA Will Hold NanoDay Virtual Research Symposium on October 9
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA. The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Regulatory Science Research in...