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September 15, 2022

FDA NanoDay Symposium 2022 Will Be Held October 11, 2022

Lynn L. Bergeson Carla N. Hutton

The U.S. Food and Drug Administration (FDA) will hold the “FDA NanoDay Symposium 2022” on October 11, 2022. The symposium will address the following topics:

  • An overview and discussion of the recent “Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials.” More information on the guidance is available in our April 24, 2022, blog item;
  • A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products;
  • A nonclinical perspective of developmental challenges of products that contain nanomaterials; and
  • The development of regulatory standards and methods for controlling products that contain nanomaterials.

According to FDA, the intended audience includes:

  • Regulatory science and regulatory affairs professionals working on drug products, including biologicals, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review;
  • Researchers working on applications of nanotechnology for pharmaceutical products, analytical methodology for control of pharmaceuticals that contain nanomaterials, and nonclinical studies to support human clinical trials; and
  • Foreign regulators who review comparable pharmaceutical products that contain nanomaterials.