All Knowledge & Insights By Date

On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration...

On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from...

The National Nanotechnology Initiative (NNI) will hold a webinar on “What We Know about NanoEHS: Building International Bridges” on March 1, 2022. NNI states that it has supported the emergence of an international community of collaborative researchers on the environmental, health, and safety aspects of nanomaterials (nanoEHS). According to NNI, “[b]y advancing tools, methods, and standards for robust health and safety evaluation, these cooperative efforts have furthered the safe and...

The Food and Drug Administration (FDA) published a Federal Register notice on October 13, 2021, announcing the withdrawal of three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”; “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and “Temporary Policy for Manufacture of Alcohol for Incorporation Into...

By Lynn L. Bergeson  On September 20, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Titled “Questions and Answers on Biosimilar Development and the BPCI Act,” the revised guidance aims to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable...

The January 29, 2021, issue of the U.S. Food and Drug Administration’s (FDA) NCTR Research Highlights includes an item highlighting the National Center for Toxicological Research’s (NCTR) nanotechnology-related activities in 2020.  The activities include:...

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...

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 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...

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...