The Center for Drug Evaluation and Research (CDER) has worked over the past several years to understand the properties of nanomaterials as they are used in drug products to inform and ensure the development of a regulatory framework that appropriately assesses the impact of their unique physical properties on safety and efficacy.
Initially, this work focused on the role of zinc oxide and titanium dioxide nanomaterials in sunscreens and CDER conducted studies to examine whether or not titanium dioxide nanomaterials penetrated normal skin (Toxicol. Sci. 2010 May;115(1):156-66). We demonstrated that in our pig model the titanium dioxide nanomaterials did not penetrate the dermis. More recently, research projects ongoing within CDER include work focused on nanomaterial characterization and safety assessment in drug products.
Ongoing CDER research projects include work to address the following:
- Identify the limitations of current test methods to assess the quality and safety of nanoparticle-based therapeutics; and
- Evaluate the application of nanotechnology on product characteristics, including stability and content uniformity.
FDA has been involved in nanotechnology research for some time. Below are several peer-reviewed research articles that has helped to inform the science.
- The evolving landscape of drug products containing nanomaterials in the United States
- How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities
- Product quality for nanomaterials: current U.S. experience and perspective
- CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products
- Development Considerations for Nanocrystal Drug Products
- Liposomal Drug Product Development and Quality: Current US Experience and Perspective
- Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products
- Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future
For further information:
Human Drug Information
Division of Drug Information (CDER)
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