FDA NanoDay Symposium 2022

The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event 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.

Highlighted topic areas include:

• Primary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials
• Development and Characterization of Generic Drug Products Containing Nanomaterials
• Considerations for the Quality, Safety and Efficacy of Prophylactic Lipid Nanoparticle mRNA Vaccines
• Case studies on the development of the COVID mRNA lipid nanoparticle vaccine products
• Future of Continuous Manufacturing of Drug Products Containing Nanomaterials
• Efforts to establish standards and standard methods for monitoring 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
• Safety Evaluation of Food Contact Substances Containing Nanomaterials

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.

Please visit the FDA’s NanoDay Symposium 2022 website for more information.

FDA RESOURCES

• GUIDANCE DOCUMENT: Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry; APRIL 2022
• GUIDANCE DOCUMENT: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology – Guidance for Industry; JUNE 2014
• GUIDANCE DOCUMENT: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; APRIL 2018
• GUIDANCE DOCUMENT: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products – Guidance for Industry; NOVEMBER 1995