Report focuses on FDA activities to improve predictivity of human and animal response to FDA-regulated products

 January 5, 2021

Media Inquiries

  Amanda Turney
  301-796-2969

The following quote is attributed to FDA Chief Scientist RADM Denise Hinton:

“The Advancing Alternative Methodologies report highlights the activities that FDA scientists are undertaking to foster the development of new regulatory approaches-—whether in our laboratories or through innovative collaborations with partners—that can help improve predictivity and potentially replace, reduce and/or refine animal testing.”

“While the FDA is committed to doing all that it can to reduce the reliance on animal-based studies, there are still many areas where animal research is necessary. Without the use of animals, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases. Animal research has played an important role in advancements such as preventing polio, eradicating smallpox and identifying new cancer treatments. We understand and share concerns that animals be involved in research only when there is no other way to fulfil an important public health objective.”

“Evaluating groundbreaking alternative methods will add to the body of knowledge that the agency can draw upon in conducting its regulatory mission and may even help bring new FDA-regulated products to consumers faster.”

Additional Information:

• The U.S. Food and Drug Administration is publishing the report, “Advancing New Alternative Methodologies at FDA,” which demonstrates the significant progress that the FDA has made in laying the groundwork for integrating alternative approaches into regulatory programs.
• Developed by the FDA’s Alternative Methods Working Group, the report and its outlined activities build upon the Predictive Toxicology Roadmap, a framework to spur the development and evaluation of emerging technologies that can help potentially replace, reduce, and/or refine animal testing and to incorporate them into the agency’s regulatory review. The roadmap ensures that the end users of this new technology—FDA regulators—are involved up front as these technologies evolve from design to testing to qualified context of use.
• As noted in the report, the FDA has developed the Advancing Alternative Methods webpage, which hosts related publications, presentations, and a webinar series that enables developers to showcase their pioneering technologies to FDA scientists. The FDA will continue to update our progress on alternatives in real time for stakeholders on our website.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.