In a significant shift, the US Food and Drug Administration (FDA) has announced its plan to reduce its reliance on animal testing for drug development. This is especially for monoclonal antibody therapies and other advanced medicines. The agency now plans to use more human-relevant technologies in order to improve safety, lower costs and also speed up the approval process.Animal History Traces Back To AgesAnimal testing has remained the cornerstone of all experiments, whether medicine or space. Since the 1930s, when the US passed the Federal Food, Drug, and Cosmetic Act in response to the tragic consequence of untested medication, animal testing was mandated. Scientists have been using mice, rats, rabbits and other animals to test for toxicity, side effects, as well ass efficacy before any new drug could be forwarded for human trial.Over the decades, this practice also helped introduce many life-saving treatments. However, it has also raised ethical concerns and scientific questions, especially on how accurately can animal models really predict human response.Why Is FDA Now Moving Away From Animal Testing?The FDA’s new initiative represents a "paradigm shift," according to its Commissioner, Dr. Martin A. Makary. There are several reasons behind this change:Limited Predictive Value: Drugs that work safely in animals don’t always perform the same way in humans. This mismatch can lead to failed clinical trials or unexpected side effects in people.Ethical Concerns: As public awareness and concern about animal welfare have grown, so too has the demand for more humane research methods.Cost and Time: Animal testing is expensive and time-consuming. Each stage of testing can take months or years and cost millions of dollars.Scientific Advancements: New technologies now offer better ways to model human biology and disease. These methods not only spare animals but also yield more accurate data.What Can Replace Animal Testing?The FDA is planning to incorporate innovative tools like computer modeling and AI, human organoids, and organ-on-a-chip technology, as well as real world human data.How Will these Work? The computer modeling and AI will allow the scientists with the help of simulations to predict how a drug will behave in the human body based on its chemical structure, genetics, and existing medical data.Furthermore, human organoids are miniature, lab-grown versions of human organs like a liver or brain which are made from stem cells. They also closely mimic how real organs function and could be used to test drug safety and effectiveness.Organ on a chip technology involves tiny chips that simulate the activity of the entire organ systems. For instance, how the heart beats or the lungs breathe. It allows for more accurate and efficient testing.The agency is also planning to rely more on existing human clinical data from other countries with comparable regulatory standards. If a drug has already been tested and used abroad, repeating animal testing for the same in the US should not be any longer a mandate.The new approach will be applied immediately to investigational new drug applications—essentially, the first step in bringing a new treatment to the U.S. market. This means that pharmaceutical companies can now submit non-animal safety data as part of their applications.Importantly, this doesn’t mean animal testing will be banned entirely. In some cases, it may still be required to answer specific safety questions. However, the goal is to make animal studies the exception, not the rule.