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.