New medicines need not be tested in animals to receive U.S. Food and Drug Administration approval, according to legislation signed by President Joe Biden.
that pushed for changes, argue that in clearing drugs for human trials the agency should rely more heavily on computer modeling, “organ chips,” and other nonanimal methods that have been developed over the past 10 to 15 years.
In order for a drug to be approved in the United States, FDA typically requires toxicity tests on one rodent species such as a mouse or rat and one nonrodent species such as a monkey or dog. Companies use tens of thousands of animals for such tests each year. Yetdrugs that enter human clinical trials fail because they are unsafe or ineffective, providing grist to those who argue that animal experiments are a waste of time, money, and lives.
Other animal alternatives include organoids—hollow, 3D clusters of cells that are derived from stem cells and mimic specific tissues. They have shown promise in predicting liver and cardiac toxicities. Proponents also tout the potential of digital artificial neural networks for rapidly identifying the toxic effects of drugs.
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