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FDA Eliminates Animal Testing: Impact on Biotechs

The Premier Consulting Blog

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).

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The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models. In this blog post, we examine several alternative approaches to animal testing and how the FDA handles the application of these methods in specific scenarios.

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Everything Wrong with Mouse Studies (Kinda)

Codon

Mice raised at five different animal facilities in Europe, under otherwise identical conditions , have “persistent differences in body weight” and behavior. There are even differences in how their genomic DNA is packaged inside of neurons. DNA differences accumulate over generations of breeding.

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