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  1. Advancing Alternative Methods at FDA

Alternative Methods Partnerships

FDA works with a wide variety of domestic and global partners across government, industry, and academia to advance alternative methods

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Scientists collaborating using a white board, illustrating alternative methods partnerships

FDA partners and interacts with numerous organizations, both in the U.S. and internationally, to help facilitate communication and collaboration to further the use of alternative methods. Examples, in alphabetical order, include: 

  • Accelerating the Pace of Chemical Risk Assessment (APCRA), an interagency work group convened by the Environmental Protection Agency (EPA) 
  • Animal-free Safety assessment of chemicals: Project cluster for Implementation of novel Strategies (APSIS) including Precision Tox, the Ontox consortium, and Risk-Hunt3R (Europe) 
  • ASTM (formerly known as American Society for Testing and Materials), Microphysiological Standards Working Group 
  • Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University 
  • EPA Office of Research and Development (ORD) New Approach Methodologies (NAMs) for Developmental Neurotoxicity (DNT) 
  • European Food Safety Authority (EFSA) Working Group on New Approach Methodologies (NAM) development for Developmental Neurotoxicity (DNT) 
  • European Organ-On-Chip Society (EUROoCS) 
  • International Liaison Group on Methods for Risk Assessment of Chemicals in Food (ILMERAC) 
  • IQ Microphysiological Systems Affiliate (IQ-MPS) of the International Consortium for Innovation and Quality in Drug Development 
  • Microphysiological Systems World Summit committee 
  • National Academies of Sciences, Engineering, and Medicine (NASEM), including Institute for Laboratory Animal Research (ILAR) and Micro-Physiological Systems for Efficacy and Safety Studies: A Workshop on Advances in Organs-On-Chip Technologies for Animals 
  • National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), including a Memorandum of Understanding (MOU) with NIH, FDA, and the Environmental Protection Agency (EPA) to further Tox21, a partnership between FDA, EPA, NIEHS and NCATS to advancing the science of toxicology and toxicity testing, and its application to regulatory decision making; and an MOU to further a common interest in facilitating the development of in vitro microphysiological systems that represent major organs and tissues in the human body, for prediction of efficacy, bioavailability and toxicity
  • National Institute of Environmental Health Sciences (NIEHS), part of NIH, Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) 
  • National Institute of Standards and Technology (NIST), Organ-on-a-Chip/Tissue-on-a-Chip Engineering and Efficacy Standardization Working Group 
  • Society of Toxicology (SOT), including the In Vitro and Alternative Methods Specialty Section (IVAM), and an MOU to collaborate on training that addresses new methods in toxicology and their qualification, as well as alternatives to animal testing 
  • United States Department of Agriculture (USDA) 

 

 

 

 
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