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                Nanotechnology Programs at FDA

Nanotechnology Programs at FDA

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          Center for Drug Evaluation and Research Nanotechnology ProgramsNanotechnology Programs at FDA Center for Drug Evaluation and Research Nanotechnology Programs
  
  	
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    PrintThe 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; andEvaluate 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 StatesHow Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance ActivitiesProduct quality for nanomaterials: current U.S. experience and perspectiveCDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug productsDevelopment Considerations for Nanocrystal Drug ProductsLiposomal Drug Product Development and Quality: Current US Experience and PerspectivePhysicochemical Characterization of Iron Carbohydrate Colloid Drug ProductsTheme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the FutureFor further information:Human Drug Information Division of Drug Information (CDER)Office of Communications10001 New Hampshire AvenueHillandale Building, 4th FloorSilver Spring, MD 20993Telephone: (888) 463-6332Email: druginfo@fda.hhs.gov

                                                                                  Content current as of:
      04/26/2018Nanotechnology Programs at FDA

          
                        Nanotechnology Guidance Documents
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