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.