Category: Research and Testing

April 6, 2021

Registration Open for April 27 NNI Webinar on “What We Know about NanoEHS: Environment”

Registration is open for the U.S. National Nanotechnology Initiative’s (NNI) April 27, 2021, webinar on “What We Know about NanoEHS:  Environment.”  The webinar will feature experts from diverse disciplines to share their perspectives on key findings on the effects of engineered nanomaterials in the environment.  Elijah Petersen, Ph.D., Research Scientist, National Institute of Standards and Technology (NIST), will moderate the panel, which will include: Jorge...
March 25, 2021

NanoHarmony Posts Recording and Slides for Webinar on Identification and Solving Barriers for Translating Science to Regulation and Standards

NanoHarmony held a webinar on March 17, 2021, on “Identification and solving barriers for translating science to regulation and standards.”  According to NanoHarmony, the webinar focused on helping to identify the obstacles faced by stakeholders in developing new test methods and having them introduced as new test guidelines and guidance documents.  A recording of the webinar is now available online, as well as the following slides: Claus Svendsen, CEH, welcome and...
March 22, 2021

EPA Issues Final Guidance for Waiving Acute Dermal Toxicity Testing

On March 17, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final guidance document entitled "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis" (EPA 705-G-2020-3722; Docket ID: EPA-HQ-OPP-2016-0093) that expands the potential for data waivers for acute dermal studies to single technical active ingredients (AI) used to formulate end-use products. This new guidance builds upon...
March 22, 2021

EUON Seeks Topic Suggestions for Future Studies on Nanomaterials

The European Union (EU) Observatory for Nanomaterials (EUON) announced on March 19, 2021, that it is looking for topic suggestions that could be addressed in its upcoming studies.  According to EUON, up to three studies are conducted annually to address knowledge gaps on nanomaterials that are of interest to the general public and the research community.  EUON states that it seeks studies that address: Questions relating to the health and safety of nanomaterials, including...
March 5, 2021

EC Calls For Applications For Expert Group On Chemicals Strategy For Sustainability

By Lynn L. Bergeson  On February 23, 2021, the European Agency for Safety and Health at Work (EU-OSHA) announced that in association with other relevant Directorates-General (DG) of the European Commission (EC), DG Environment has opened a call for applications to select members for an expert group, the High-Level Roundtable on Implementation of the Chemicals Strategy for Sustainability. According to EU-OSHA, the expert group’s mission “is to set the Chemicals Strategy for...
March 4, 2021

Registration Opens for NNI Webinar on “What We Know About NanoEHS: Human Exposure”

Registration is open for the U.S. National Nanotechnology Initiative’s (NNI) March 23, 2021, webinar on “What We Know About NanoEHS:  Human Exposure.”  The webinar will feature experts from diverse disciplines to share their perspectives on key findings in quantifying and assessing the effects of human exposure to nanomaterials.  Keana Scott, Ph.D., Physical Scientist, Materials Measurement Science Division, National Institute of Standards and Technology...
March 3, 2021

NIEHS-Funded Study Finds Graphene Nanochannel Filters Hold Promise for Contaminant Clean-Up

The March 2021 issue of Environmental Factor, a monthly newsletter published by the National Institute of Environmental Health Sciences (NIEHS), includes an item entitled “New graphene nanochannel filters hold promise for contaminant clean-up.”  According to the item, an NIEHS-funded study found a new strategy to design nanomaterials to filter contaminants better from water.  To improve the usefulness of graphene oxide nanosheets for filtering contaminants from liquid, the...
February 10, 2021

EC DG Invites Offers for Study on Providing Market Data about Nanotechnology to Enhance Transparency

In December 2020, the European Commission (EC) Directorate-General (DG) for Research and Innovation opened a call for tenders for “Providing market data about nanotechnology to enhance transparency.”  The description states that the study on nanotechnology/nanomaterials is aimed to provide a new set of data from the period of 2017 to 2020 into the NanoData database, available on the European Union (EU) Observatory for Nanomaterials (EUON) website.  This study will follow up on...
February 5, 2021

EPA Updates Modeling Tool That Evaluates Chemical’s Potential To Cause Cancer

By   Lynn L. Bergeson  EPA announced on January 8, 2021, that it released an updated and improved version of OncoLogic™, a system used to evaluate a chemical’s potential to cause cancer. EPA states that, in partnership with the Organization for Economic Cooperation and Development (OECD), it developed “a more user-friendly version of the most widely used piece of this system, greatly expanding its usability across the agency and the scientific community.”...
February 5, 2021

Court Grants EPA’s Motion To Vacate And Remand Final Rule On “Strengthening Transparency In Pivotal

By Lynn L. Bergeson  On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469). EDF v. EPA, No. 4:21-cv-03-BMM. On January 11, 2021, the Environmental Defense...
February 2, 2021

OECD Will Hold Webinar on Assessing the Dispersion Stability and Dissolution of Nanomaterials in the Environment

On February 25, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on “Assessing the dispersion stability and dissolution (rate) of nanomaterials in the environment” to discuss the scope, content, and use of Test Guideline No. 318:  Dispersion Stability of Nanomaterials in Simulated Environmental Media and its accompanying guidance document.  According to OECD, “[t]he increased production and wide usage of manufactured...
January 21, 2021

Registration Opens for NNI Webinar on “What We Know about NanoEHS: How It All Began”

Registration is now open for the U.S. National Nanotechnology Initiative’s (NNI) February 9, 2021, webinar, “What We Know about NanoEHS:  How It All Began.”  NNI states that its 2021 NanoEHS webinar series will focus on sharing what it now knows about the environmental, health, and safety aspects of engineered nanomaterials (nanoEHS).  According to NNI, throughout the series, “experts will share the big take-home EHS messages with the broader nanotechnology...
January 8, 2021

Swansea University Researchers Develop One-Step Method For Producing Porous Carbon Spheres

By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A. Researchers at Swansea University’s Energy Safety Research Institute have developed a new method that produces spheres that have strong capacity for carbon capture and work at a large scale. Described as “[a] fast, green and one-step method for producing porous carbon spheres, which are a vital component for carbon capture technology and for new ways of storing renewable energy,” the method was developed by a...
January 8, 2021

Sigma Xi Now Accepting Nominations For Various Prizes And Awards

By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The Scientific Research Honor Society (Sigma Xi) is accepting nominations until January 31, 2021, for awards that recognize achievements in science or engineering research and communication. Nominations are being accepted for the following awards: Gold Key Award – Presented to an individual who has made contributions to their profession and fostered critical innovations to enhance the health of the research enterprise,...
January 5, 2021

NIOSH Science Blog Reports on Recent Article Concerning Carbon Nanotubes and Nanofibers Used or Produced in U.S. Facilities

On January 5, 2021, the National Institute for Occupational Safety and Health (NIOSH) posted a Science Blog item entitled “Understanding the Broad Class of Carbon Nanotubes and Nanofibers (CNT/F) Used or Produced in U.S. Facilities.”  The item summarizes a recently published article in the journal Particle and Fibre Toxicology, “Physicochemical characterization and genotoxicity of the broad class of carbon nanotubes and nanofibers used or produced in U.S. facilities” that...
December 30, 2020

OECD Will Hold Webinar on Aquatic and Sediment Ecotoxicity Testing of Nanomaterials

On January 26, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials (No. 317).  The webinar will discuss the scope and use of the guidance document, which addresses practical aspects of carrying out valid tests on nanomaterials, and modifications or additions to OECD Test Guidelines procedures intended to improve the accuracy of test...
December 23, 2020

OECD Publishes Report on Ability of Biopersistent/Biodurable Manufactured Nanomaterials to Induce LMP as a Prediction of Their Long-Term Toxic Effects

The Organization for Economic Cooperation and Development (OECD) has posted a report entitled Ability of biopersistent/biodurable manufactured nanomaterials (MNs) to induce lysosomal membrane permeabilization (LMP) as a prediction of their long-term toxic effects.  The report describes “the expanding knowledge on the implications and biological significance of lysosomal and autophagy dysfunction and the subsequent assembly and activation of inflammasome NLRP3 induced by biodurable...
November 23, 2020

Registration Opens for 2021 NNI Strategic Planning Stakeholder Workshop

Registration is now open for the National Nanotechnology Initiative’s (NNI) 2021 NNI Strategic Planning Stakeholder Workshop:  Charting the Path Forward, which will be held January 11-13, 2021.  NNI states that over the past 20 years, it has supported nanotechnology discovery, development, and deployment and has nurtured the strong ecosystem that exists today.  Building on this foundation, nanoscience will underpin a wide range of advanced technologies and enable...
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 2, 2020

Register Now for SNO and NanOEH’s Virtual Nanotechnology Conference on November 12 and 13, 2020

The Sustainable Nanotechnology Organization (SNO) and the Nanotechnology, Occupational and Environmental Health (NanOEH) Committee have partnered to present the 9th NANO Conference.  This conference combines the interests of SNO and NanOEH by offering a virtual program containing sessions that are of interest to both groups. SNO is a permanent non-profit corporation that provides the infrastructure to carry out its mission of research, education, and responsibility related to both...
October 28, 2020

EPA Seeks Comment on Its Interim Guidance on Residual Efficacy Claims

On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses.  This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes...
October 27, 2020

NNI Publishes Supplement to President’s 2021 Budget Request

On October 27, 2020, the U.S. National Nanotechnology Initiative published the National Nanotechnology Initiative Supplement to the President’s 2021 Budget (Supplement), which serves as the annual report for NNI, called for under the provisions of the 21st Century Nanotechnology Research and Development Act.  According to the Supplement, the President’s 2021 budget requests more than $1.7 billion for NNI, with an increased investment in the foundational research intended to lead to...
October 26, 2020

NNI Strategic Planning Stakeholder Workshop Will Be Held in January 2021

The U.S. National Nanotechnology Initiative (NNI) will hold a virtual stakeholder workshop January 11-13, 2021.  NNI states that over the past 20 years, it has supported nanotechnology discovery, development, and deployment and has nurtured the strong ecosystem that exists today.  Building on this foundation, nanoscience will underpin a wide range of advanced technologies and enable solutions to challenges into the future.  As NNI enters its third decade, conversations...
October 21, 2020

EPA’s Draft Residual Efficacy Protocols for “Long-Lasting” Efficacy for Antiviral Products

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  EPA’s guidance specifies scientific testing requirements for two different types of products:  (1) disinfectants that also provide residual efficacy, and (2)...
October 14, 2020

EPA Announces Guidance to Waive Toxicity Tests on Animal Skin

On October 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse effects.  This new draft guidance is part of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by...
October 14, 2020

EPA Announces Expedited Pathway for Companies to Claim “Long-Lasting” Efficacy for Antiviral Products

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  As most know, 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,...
October 13, 2020

NSET Subcommittee Seeks Input on 2021 NNI Strategic Plan

On October 13, 2020, the Nanoscale Science, Engineering and Technology (NSET) Subcommittee published a request for information to inform the development of the 2021 National Nanotechnology Initiative (NNI) Strategic Plan.  85 Fed. Reg. 64535.  According to the Subcommittee, a restructuring of the NNI is under consideration.  The Subcommittee seeks response to the following questions to identify effective mechanisms, strategies for communication, and priority...
October 7, 2020

Public Consultation Begins on SCCS Scientific Advice on Safety of Nanomaterials in Cosmetics

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on October 5, 2020, on a preliminary opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics.  The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4)...
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...
September 22, 2020

NSF Will Invest $84 Million in National Nanotechnology Coordinated Infrastructure

The National Science Foundation (NSF) announced on August 24, 2020, that it will invest a total of $84 million over five years in a renewal of the National Nanotechnology Coordinated Infrastructure (NNCI).  According to NSF, “NNCI’s 16 sites and coordinating office provide researchers from academia, large and small businesses, and government with access to leading-edge fabrication and characterization tools, instrumentation, and expertise across all disciplines of nanoscale...
September 18, 2020

EFSA Calls for Grant Proposals on the Use of NAMs for the Hazard Assessment of Cellulose Nanofibers

On September 15, 2020, the European Food Safety Authority (EFSA) called for grant proposals on the use of new approach methodologies (NAM) for the hazard assessment of cellulose nanofibers.  EFSA states that the use of cellulose at the nanoscale is increasing and requires an assessment.  According to EFSA, the main concern is that the nanoscale characteristics (e.g., length/shape of the fibers) may influence the toxicokinetic and hazardous properties of cellulose nanofibers....
September 14, 2020

2020-2021 NNI NanoEHS Webinars Will Begin in November 2020

According to the Summer 2020 edition of the National Nanotechnology Coordination Office (NNCO) Quarterly Newsletter, the 2020-2021 National Nanotechnology Initiative (NNI) nanomaterial environmental, health, and safety (nanoEHS) webinars will begin in November 2020.  According to the Newsletter, the Nanotechnology Environmental and Health Implications (NEHI) Working Group is planning nanoEHS webinars to present progress in the following areas:  nanomaterial...
September 4, 2020

EPA Calls For Nominations For 2021 Green Chemistry Challenge Awards

By Lynn L. Bergeson  On August 17, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is accepting nominations for the 2021 Green Chemistry Challenge Awards. EPA intends these awards to recognize innovation by American businesses and researchers that redesign chemical products and processes to reduce or eliminate the use and manufacture of hazardous substances. The 2021 Green Chemistry Challenge Awards nomination package is now available, and nominations are due...
August 24, 2020

2020 NanoEHS U.S.-EU COR Workshop Will Be Held September 16-17

The U.S. National Nanotechnology Initiative (NNI) and European Commission (EC) have organized the ninth annual meeting of the environmental, health, and safety effects of nanomaterials (nanoEHS) Communities of Research (COR) as a virtual workshop on September 16-17, 2020.  According to NNI, as the nanoEHS research ecosystem continues to evolve, the workshop will identify future needs and opportunities.  Conversations will further address how the lessons learned from...
August 19, 2020

September Webinar Will Review How OECD Develops Test Guidelines

The European Union (EU)-funded projects NanoHarmony and NANOMET-Organization for Economic Cooperation and Development (OECD) have jointly organized a September 16, 2020, webinar on “The Pathway to Test Guidelines:  from science to standards for nanomaterials.”  Participants will learn how OECD develops Test Guidelines, using case studies from the Test Guidelines that are supported through the projects for expansion into nanomaterials.  The webinar will explain how novel...
August 12, 2020

NanoExplore Recruiting Companies in Certain EU Member States to Participate in Study of Occupational Exposure to Nanomaterials

The NanoExplore project, which is supported by the European Union’s (EU) LIFE program, aims at an integrated approach for exposure and health effects monitoring of engineered and incidental nanomaterials in occupational settings.  The project is currently in its pilot phase.  According to NanoExplore, the pilot study will take place following a two-step procedure over two field campaigns separated by a six- or nine-month interval.  Each field campaign will last for four...
July 27, 2020

OECD Publishes Guidance Documents for the Testing and Assessment of Nanomaterials

The Organization for Economic Cooperation and Development (OECD) recently published two guidance documents in its series on testing and assessment: Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials (No. 317): The guidance document addresses practical aspects of carrying out valid tests with manufactured nanomaterials, as well as modifications or additions to OECD Test Guideline procedures intended to improve incrementally the accuracy, intra-laboratory...
July 21, 2020

NIEHS Grantees Construct New Database to Facilitate Nanomaterial Research

The July 2020 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an item on a new database that facilitates nanomaterial research.  According to the article, NIEHS grantees constructed PubVINAS, “a large database of structure, chemical property, and activity information on 705 nanomaterials, covering 11 material types.”  The article states that the extensive data on each material “allows scientists...
July 8, 2020

ISO Publishes Standards Regarding Measurements of Nanoparticle Size and Shape Distribution and Polymeric Nanocomposite Films for Food Packaging with Barrier Properties

The International Organization for Standardization (ISO) has published two nanotechnology standards: ISO 21363:2020, “Nanotechnologies — Measurements of particle size and shape distributions by transmission electron microscopy”: The standard specifies how to capture, measure, and analyze transmission electron microscopy images to obtain particle size and shape distributions in the nanoscale.  According to ISO, the standard is broadly applicable to nano-objects, as well as to particles...
July 6, 2020

Germany Publishes Overview of Field of Advanced Materials

In July 2020, the German Environment Agency (UBA) published a report entitled Advanced materials:  Overview of the field and screening criteria for relevance assessment.  The report describes activities within the project “Advanced materials — Thematic conferences:  Assessment of needs to act on chemical safety” to provide discussion input on approaches to describe, cluster, and prioritize advanced materials.  The aim of the report is to identify relevant advanced...
June 26, 2020

NIOSH Publishes Program Performance One-Pager for Nanotechnology Research Center

On June 25, 2020, the National Institute for Occupational Safety and Health (NIOSH) published a Nanotechnology Research Center (NTRC) Program Performance One-Pager (PPOP).  NTRC conducts research to understand the potential effects on human health of exposure to engineered nanomaterials (ENM) and develops methods to control or eliminate exposures.  According to the PPOP, NTRC’s accomplishments include conducting a survey to gather information about companies’ safety and...
June 25, 2020

EU NanoSafety Cluster Holding Webinar on June 30 on Immune Response from Occupational Exposure to Carbon Nanotubes and Carbon Nanofibers

On June 30, 2020, from 9:00 a.m.-10:30 a.m. (EDT), the European Union (EU) NanoSafety Cluster will hold a webinar on “Immune response from occupational exposure to CNTs and nanofibres.”  The following speakers will discuss work at the U.S. Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) on the association of occupational exposure with ex vivo functional immune response in workers handling carbon nanotubes and...
June 8, 2020

NNI Will Hold Webinar on Advances in Self-Powered Wearable Sensors

The U.S. National Nanotechnology Initiative (NNI) will hold a webinar on June 24, 2020, on “Advances in self-powered wearable sensors:  A biofuel-powered electronic skin.”  NNI states that the development and commercialization of self-powered, battery-free sensors with wireless capabilities would represent a significant step toward meeting the requirements for next-generation biosensors, medical devices, and robotics.  Dr. Wei Gao, California Institute of Technology, will...
June 3, 2020

NanoHarmony Project Will Hold Introductory Webinar in July

The Nanotechnology Industries Association (NIA) will hold a webinar on July 7, 2020, on “Introducing the NanoHarmony project.”  Funded through Horizon 2020, NanoHarmony began on April 1, 2020.  NanoHarmony brings together 14 expert partners from ten European countries and will work alongside the Organization for Economic Cooperation and Development (OECD) and European Chemicals Agency (ECHA) to support the development of test guidelines and guidance documents for...
May 27, 2020

EU NanoSafety Cluster Publishes Final Report of (nano) TiO2 Safety Communication Task Force

On May 26, 2020, the European Union (EU) NanoSafety Cluster announced the publication of the final report of the (nano) TiO2 safety communication Task Force.  The goal of the task force was to provide scientific input to the ongoing classification of titanium dioxide (TiO2).  The Task Force ran from January 2018 to January 2019, collecting information regarding the classification of TiO2 and information on TiO2 hazard potential from available...
May 22, 2020

Study Analyzes Existing Research on Dermal Absorption of Nanomaterials Used in Consumer Products and at Workplaces

The European Union (EU) Observatory for Nanomaterials (EUON) announced on May 20, 2020, that a recent study has analyzed existing research on whether nanomaterials used in consumer products and at workplaces are absorbed through the skin.  The study was commissioned by EUON and carried out by the RPA consortium of Triskelion and the Dutch National Institute for Public Health and the Environment (RIVM).  According to EUON, the study found that the lack of standardized,...
May 13, 2020

WHO Publishes Principles and Methods to Assess Risk of Immunotoxicity Associated with Exposure to Nanomaterials

On April 12, 2020, the World Health Organization (WHO) published Environmental Health Criteria 244:  Principles and methods to assess the risk of immunotoxicity associated with exposure to nanomaterials.  WHO states that the document presents an overview of the current knowledge and evidence on principles and basic mechanisms of immunotoxicity caused by engineered nanomaterials (ENM).  The document provides guidance on principles and methods for hazard and risk assessment of...
May 8, 2020

National Academies Will Hold Briefing Webinar on Quadrennial Review of NNI

As reported in our April 8, 2020, blog item, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a prepublication copy of A Quadrennial Review of the National Nanotechnology Initiative:  Nanoscience, Applications, and Commercialization.  The National Nanotechnology Coordination Office (NNCO) asked the National Academies to form an ad hoc committee to conduct a quadrennial review of the National Nanotechnology Initiative (NNI)...
April 18, 2020

NanoHarmony Will Hold Webinar in May in the “Improving the OECD Test Guidelines Process” Series

On May 4, 2022, NanoHarmony will hold a webinar in its series of webinars covering the different phases that an Organization for Economic Cooperation and Development (OECD) test guideline (TG) progresses through during its journey from a science-based initial idea through to use by industry to fulfill regulatory obligations. This webinar will cover phases 2 and 3 of the TG process, technical development and commenting and approval. Speakers will include: Chair Claus Svendsen, United Kingdom...
April 17, 2020

FDA Requests Comments On Product User Fee Programs

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an...