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NCL Partnerships - FDA

U.S. Food and Drug AdministrationU.S. Food and Drug Administration (FDA)

The NCL serves as a bridge to take promising cancer nanotechnology research to the FDA. FDA provides input to NCL on the type of testing needed to evaluate nanomaterials for regulatory review, and data generated at NCL inform FDA on which nanoparticle properties contribute most to safety and toxicity. Additionally, the NCL provides the FDA with collaborative research resources.

NCL interfaces with FDA on a number of levels. Senior FDA personnel participate on NCLs Scientific Oversight Committee (SOC) to review NCL-generated data and to ensure that NCLs assays are capturing important aspects of characterization that are relevant for regulatory submission. The NCL director interfaces with FDA policymakers on national-level committees such as those sponsored by the National Nanotechnology Initiative (NNI). NCL staff actively collaborate and communicate with FDA scientists and reviewers to address specific scientific challenges in nanomedicine, such as characterization of nanomaterials in biological matrix. FDA and NCL also co-sponsor workshops, seminars, and meetings for standards development and characterization of nanomaterials.

Some highlights of the NCL-FDA collaboration are:

  • In July 2007 NCL hosted FDA for the NCL-FDA Data Review on Nanotechnology-Based Therapeutics on the NCI-Frederick campus.
  • In 2008, the NCL initiated a study of the stability of various nanoparticles under conditions mimicking those used to sterilize medical devices in collaboration with the FDAs Center for Devices and Radiological Health (CDRH).
  • In September 2008, the FDA held a request for comment related to a public meeting on "Consideration of FDA-Regulated Products That May Contain Nanoscale Materials" and NCL participated in the meeting and submitted comments for the public docket. NCL also hosted a visit and tour of its facilities for FDA chemists.
  • In 2008-2009, the NCL continued its work on a collaborative FDA-NCL study of the penetration of nanoscale titanium dioxide particles in rodents, pig skin, and human skin. This question is of great interest to the FDA since nearly all modern sunscreens contain nanoscale titanium dioxide or zinc oxide, which are colorless and scatter light more efficiently than larger particles of the same material. Some consumer advocates have expressed concern that these nanoparticles could pose risks to the skin or, if they penetrate the skin, to other parts of the body. The FDA has received a Citizens Petition requesting they require manufacturers to declare currently available sunscreen drug products containing engineered nanoparticles as an imminent hazard to public health. However, many studies have found no evidence that sunscreens or cosmetics that contain nano-size mineral components constitute a health hazard. The NCL-FDA study addresses the issue of dermal penetration of titanium dioxide nanoparticles, and has resulted in two collaborative publications:

    "Energy dispersive X-ray analysis of titanium dioxide nanoparticle distribution after intravenous and subcutaneous injection in mice" by A Patri, T Umbreit, J Zheng, K Nagashima, P Goering, S Francke-Carroll, E Gordon, J Weaver, T Miller, N Sadrieh, SE McNeil, M Stratmeyer, Journal of Applied Toxicology 29(8):662-672, 2009.

    "Lack of Significant Dermal Penetration of Titanium Dioxide (TiO2) from Sunscreen Formulations containing Nano- and Sub-Micron-Size TiO2 Particles" by N Sadrieh, AM Wokovich, NV Gopee, J Zheng, D Haines, D Parmiter, PH Siitonen, CR Cozart, AK Patri, SE McNeil, PC Howard, WH Doub and LF Buhse, Toxicological Sciences 115(1):156-66, 2010.

  • In 2009, the NCL initiated a collaboration with FDAs National Center for Toxicological Research (NCTR). NCTR is the FDAs internationally recognized research center in Jefferson, Arkansas. NCL and NCTR plan to conduct GLP-quality pharmacokinetic studies in primates, in support of NCL-collaborator IND applications, and to provide primate data for interspecies pharmacokinetic comparisons. Measures of toxicity, specifically immunotoxicity, that are amenable to blood analysis will also be included in these studies.
National Cancer InstituteDepartment of Health and Human ServicesNational Institutes of HealthFirstGov.govNCI - Alliance for Nanotechnology in Cancer
National Cancer Institute U.S. National Institutes of Health Nanotechnology Characterization Lab