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Nanotechnology—Over a Decade of Progress and Innovation

The US FDA released a report summarizing the agency's efforts in the field of nanotechnology. The report "Nanotechnology—Over a Decade of Progress and Innovation" can be accessed online here: You can also watch Dr. Anil Patri, Chair of the FDA Nanotechnology Task Force, present on the topic August 13th. Details and registration for thew webinar are here:

The report details the agency's efforts in regulatory-centered research, regulatory training for its staff, efforts in standards development and more.

The report also summarizes the agency's guidance for industry documents currently available for nanotechnology-based products:

  • Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, June 2014

  • Final Guidance for Industry: Safety of Nanomaterials in Cosmetic Products, June 2014

  • Final Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives, June 2014

  • Final Guidance for Industry: Use of Nanomaterials in Food for Animals, August 2015

  • Final Guidance for Industry: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation, April 2018

  • Draft Guidance for Industry – Drug Products, Including Biological Products, that Contain Nanomaterials, December 2017