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September 29, 2023

FDA Will Hold 2023 NanoDay Symposium on Continuous Manufacturing of Nanomaterials

Lynn L. Bergeson Carla N. Hutton

The U.S. Food and Drug Administration (FDA) will hold a virtual 2023 NanoDay symposium on October 11, 2023, on the continuous manufacturing of nanomaterials. In the symposium, FDA will provide an overview of Center for Drug Evaluation and Research (CDER) experience with approving several solid oral drug products that benefited from the continuous manufacturing technologies. FDA states that it will also provide case studies of intramural and extramural research in the areas of nanomaterials and continuous manufacturing to encourage further the innovation and adoption of continuous manufacturing. Lastly, FDA will discuss ways in which industry, academia, and other regulatory agencies can collaborate and engage with FDA in advancing the field of nanotechnology and continuous manufacturing. The topics covered will include:

  • CDER experience in approving solid oral drug products using continuous manufacturing;
  • FDA extramural research on various types of continuous manufacturing technologies for liposomes and lipid nanoparticles;
  • FDA intramural research on characterization of drug products containing nanomaterials;
  • Regulatory considerations on nanomaterial drug products; and
  • Ways to engage with FDA on regulatory science research.

Registration is open.