September 20, 2020

Volume X, Number 264

September 18, 2020

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FDA Publishes Report on Nanotechnology — Over a Decade of Progress and Innovation, Will Hold Webinar on August 13

The U.S. Food and Drug Administration (FDA) published a report entitled Nanotechnology — Over a Decade of Progress and Innovation that highlights FDA’s advancements in the field of nanotechnology since it released its last report in 2007.  The report also reviews FDA’s role in advancing the public health through its regulation of products within its jurisdiction that involve the application of nanotechnology.  According to the report, FDA “will rely on a combination of horizon-scanning activities to stay abreast of new developments and product applications, including by”:

  • Participating in scientific and trade forums;

  • Participating in standards development;

  • Continuing discussions with national and international counterparts;

  • Monitoring scientific and trade literature;

  • Engaging with academia and developers; and

  • Performing prospective regulatory science on emerging technologies.

In addition, FDA states that its Emerging Sciences Working Group, a cross-agency, science-based forum established in 2016, continues to identify science and technology trends of relevance to FDA’s regulatory responsibilities, including those for nanotechnology products.  FDA notes that its “science-based, product-focused regulatory framework is sufficiently flexible and robust to help ensure product safety (and effectiveness, as applicable) while supporting innovation for the development of beneficial nanotechnology products.”

On August 13, 2020, FDA will hold a webinar to present the report.  The webinar will include the basics of nanotechnology and will highlight the facilities, regulatory science research, guidance documents, standards, domestic and international collaborations, and emerging challenges in regulatory science.  The speaker will be Anil K. Patri, Ph.D., Chair, Nanotechnology Task Force, Director, Nanocore, National Center for Toxicological Research (NCTR)/FDA.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 223


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...

Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
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 initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.