Drugs

Product Testing Alternative Methods

FDA has launched a Web page devoted to its efforts to research and promote alternative methods for product testing. The page says alternative methods “have the potential to provide more timely and more predictive information to assess certain aspects of FDA-regulated products while also replacing, reducing, and/or refining animal testing.”

Examples of alternative approaches, FDA says, are:

systems biology (evaluating multiple aspects of cell and tissue responses to study the whole organism);
engineered tissues (using scaffolds and cells to form biologically active tissues);
artificial intelligence (using computer approaches);
alternative organisms such as zebrafish and C. elegans; and
microphysiological systems, including organs on chips.

According to the Web page, FDA is conducting research that supports alternative methods and has a regulatory framework that permits the use of alternatives.

FDA says its New Alternative Methods Program is intended to spur the adoption of alternative methods for regulatory use to replace, reduce, and refine animal testing; help prevent products with increased toxicological risk from reaching the market; and improve the predictivity of nonclinical testing to streamline the development of FDA-regulated products. “FDA recognizes alternative methods also may provide opportunities to assess potential toxicities, risks, safety, and effectiveness, and give insight into disease processes,” it says. The program is assigned to the Office of the Chief Scientist.

The paper lists FDA guidances that reference alternative method approaches and describes the efforts of three cross-agency working groups: Alternative Methods Working Group, Modeling and Simulation Working Group, and Technology Working Group.

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