FDA Announces Plans to Gradually Eliminate Animal Testing in Drug Development
“This initiative signifies a transformative change in drug assessment,” stated the FDA’s commissioner.
On April 10, the Food and Drug Administration (FDA) announced plans to gradually eliminate animal testing for monoclonal antibodies and various other pharmaceuticals.
According to FDA representatives, the agency’s requirements for animal testing will be “reduced, refined, or potentially substituted” with innovative alternatives, such as advanced computer modeling that employs artificial intelligence and lab-grown products that replicate human organ functions.
Additionally, the agency will begin evaluating existing real-world safety data from other nations with regulatory frameworks comparable to those in the United States.
He noted that this decision “represents a significant advancement toward eliminating laboratory animals from drug testing protocols.”
According to the FDA, companies that present robust safety data derived from non-animal testing could experience expedited review processes.
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Health Secretary Robert F. Kennedy Jr. remarked during a Cabinet meeting in Washington that officials have discovered that artificial intelligence “is significantly more accurate in determining the effects of toxins in various products.”
The FDA Modernization Act 2.0, enacted in 2022, paved the way for this change by eliminating the necessity for new drug sponsors to conduct animal studies in order to obtain regulatory approval.
Conversely, the National Association for Biomedical Research expressed concerns that there are currently no complete substitutes for animal models in drug development.
