GATC Health Welcomes the FDA Modernization Act 2.0, Allowing New Drug Candidates to Bypass Animal Testing
This legislation is expected to create more demand for GATC's drug discovery and development platform as AI and machine learning are increasingly used in advancing drug leads to human trials
IRVINE, Calif., Jan. 25, 2023 /PRNewswire/ -- GATC Health, a science and technology company revolutionizing drug discovery and disease prediction using artificial intelligence (AI), today announced that the FDA Modernization Act 2.0 signed into law in December 2022, ends an FDA mandate that experimental drugs must be tested on animals before they are used on humans in clinical trials. The new legislation allows emerging technologies, including GATC's computer modeling that predicts a potential drugs safety and efficacy in humans, to be used to advance drug leads to human trials without the requirement of animal testing.
FDA Modernization Act 2.0 is expected to create more demand for GATC's drug discovery and development platform.
In 1938, Congress passed the U.S. Federal Food, Drug, and Cosmetic Act, mandating animal toxicity testing. Since then, science and data has shown that animal testing is highly inconsistent in predicting toxic responses in humans. More than nine in 10 drugs that enter FDA human clinical trials fail and do not get to market because they are unsafe or ineffective. The new FDA Modernization Act 2.0 stipulates that new drug candidates are no longer required to undergo animal testing prior to initiation of human trials and signals a major shift towards computer modeling as the preferred method to simulate the safety and efficacy of novel compounds in humans before drugs are approved by the FDA.
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