FDA NanoDay Symposium 2022
October 11, 2022 | 8:50 AM - 3:10 PM Eastern
This symposium will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. FDA speakers will present reviewer perspectives on drug development and laboratory efforts to facilitate further understanding of challenges to manufacture products that contain nanomaterials. Two additional speakers will address safety evaluations of foods to contact surfaces that contain nanomaterials and the development of standard materials and methods for nanomaterials.
FDA will discuss the primary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials
FDA will provide case studies on the development of the COVID mRNA lipid nanoparticle vaccine products
FDA will present efforts to establish standards and standard methods for monitoring products that contain nanomaterials
TOPICS COVERED
An overview and discussion of the recently finalized “Guidance to Industry: Drug Products, Including Biological Products, that Contain Nanomaterials”
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
The development of regulatory standards and methods for controlling products that contain nanomaterials