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  1. About Science & Research at FDA

Advancing Alternative Methods at FDA

Alternative methods to traditional toxicity and efficacy testing
Advancing Alternative Methods at FDA

FDA’s Alternative Methods Working Group


Advances in systems biology, stem cells, engineered tissues, and mathematical modeling are creating unique opportunities to improve FDA's predictive ability, potentially enhancing our ability to predict risk and efficacy.

These advances may help bring FDA-regulated products to market faster, with improved efficacy, or prevent products with increased toxicological risk from reaching the market. Also critical is the potential for these advances to replace, reduce, and/or refine animal testing. 

FDA has had a long-standing commitment to promote the development and use of new technologies to better predict human and animal responses to substances relevant to its regulatory mission.  As part of efforts to strengthen that commitment, FDA launched its Alternative Methods Working Group (Alternative Methods Group).

FDA invites developers to showcase their cutting-edge technologies in FDA Webinar Series on Alternative Methods

FDA's Alternative Methods Group focuses on opportunities for evolving and innovative technologies to advance useful tools as well as new areas of science to support alternative methods to traditional toxicity and efficacy testing that extend across FDA’s product areas.

It also acts as a catalyst to foster the development and potential application of alternative systems (in vitro, in vivo, in silico, and systems toxicology modeling), such as microphysiological systems, to support decision-making in regulatory toxicology.

The Alternative Methods Group facilitates interactions with global regulatory bodies interested in implementing alternative methods in toxicology.  Additionally, it examines opportunities and viable ways by which emerging methods and new technologies can support regulatory review of risk, safety, and efficacy of FDA-regulated products.

The activities of FDA's Alternative Methods Group are informational and do not serve as official regulatory guidance.

Objectives of FDA's Alternative Methods Working Group

  • Discuss FDA-wide new in vitro, in vivo, and in silico methods, including research, training, and communication.
  • Engage with U.S. Federal partners and global partners to promote discussion, development, and acceptance of regulatory performance criteria for such assays.
  • Establish a dialogue and develop partnerships with FDA stakeholders to explore regulatory science applications for such technologies.
  • Identify the performance criteria of microphysiological systems by engaging with FDA experts and FDA stakeholders through public-private partnerships.

FDA Draft Definitions

Microphysiological System (MPS): A microphysiological system is an in vitro platform composed of cells; explants derived from tissues/organs; and/or organoid cell formations of human or animal origin in a micro-environment that provides and supports biochemical/electrical/mechanical responses to model a set of specific properties that define organ or tissue function.

Organ-on-a-chip: Organ-on-a-chip is a miniaturized physiological environment engineered to yield and/or analyze functional tissue untis capable of modeling specified/targeted organ-level responses. 

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An FDA/CDER perspective on nonclinical testing strategies: Classical
toxicology approaches and new approach methodologies (NAMs)

Opportunities for use of one species for longer-term toxicology testing
during drug development: A cross-industry evaluation



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