December 8, 2021

Volume XI, Number 342

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December 07, 2021

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December 06, 2021

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FDA’s NCTR Highlights Its Nanotechnology-Related Activities in 2020

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:

  • Nanotechnology Standards:  Two work items developed by the NCTR Nanotechnology Core Facility (Nanocore) staff became standards in February 2019 and January 2020 (Standard Practice for Performing Cryo-Transmission Electron Microscopy of Liposomes and Standard Test Method for Quantitative Measurement of the Chemoattractant Capacity of a Nanoparticulate Material in vitro, respectively) and are available through ASTM International.  Seven additional work items developed by the NCTR Nanocore scientists are going through the consensus-standard process at ASTM International E56 for quality assurance and testing for biocompatibility;

  •  Nanotechnology Task Force Report:  The Nanotechnology Task Force (NTF) published a comprehensive progress report, Nanotechnology — Over a Decade of Progress and Innovation, in July 2020.  The report highlights the current state of science in nanotechnology and the progress at FDA in research, infrastructure, guidance, standards, interagency engagement, and international engagement;

  • FDA Grand Rounds:  The FDA Grand Rounds seminar, “Nanotechnology:  Over a Decade of Progress and Innovation at FDA,” was presented by Anil Patri, Ph.D., Nanocore Director, on August 13, 2020.  The seminar highlighted NTF’s July 2020 report on the progress FDA has made in nanotechnology since 2007.  Also discussed were the basics of nanotechnology, FDA facilities overview, regulatory science research at FDA, guidance documents, standards, domestic and international collaborations, and emerging challenges in regulatory science; and

  • Nano Day:  FDA’s Nano Day Virtual Research Symposium:  “A Decade of Progress and Innovation in Nanotechnology at U.S. FDA,” was organized by NCTR and hosted by NTF on October 9, 2020.  The 3.5-hour virtual event drew more than 300 participants from around the globe and highlighted NTF’s July 2020 report and regulatory science research conducted at FDA.  Additionally, a virtual tour of FDA’s nanotechnology facilities was provided.  More than 20 speakers gave presentations that highlighted the collaborative efforts within FDA, other government agencies, and academia and demonstrated the expertise and strength within FDA to promote and protect public health.  

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 30
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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