FDA publishes report on advancing alternative methods

The U.S. Food and Drug Administration has published 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 its progress on alternatives in real time for stakeholders on its 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 the U.S. food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.