The Food and Medicines Administration of the United States is taking an innovative step to advance public health by replacing animals in the development of monoclonal antibody therapies and other medications with more effective and relevant human methods.
The new approach is designed to improve the safety of medicines and accelerate the evaluation process, while reducing animal experimentation, reducing research and development costs (R&D) and, ultimately, medication prices.
The FDA animal test requirement will be reduced, refined or replaced potentially using a variety of approaches, including computational models based on AI of toxicity and cell lines, and organic toxicity tests in a laboratory environment. The implementation of the regime will begin immediately for the applications of New Research Drug (IND), where the inclusion of NAMS data is encouraged and described in a road map.
To determine the efficacy, the agency will also begin to use pre -existing security data from the real world of other countries, with comparable regulatory standards, where the medicine already has legs of humans in humans, he added.
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Posted on April 20, 2025