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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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Future-proofing drug development with GenAI

Drug Target Review

With up to 90 percent of assets never making it to market when competition is at an all-time high, it is worth discussing how AI-driven approaches might help set a stronger foundation for possibilities downstream. FDA news release, “FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs.”

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Time for change: non-human primates in drug research

Drug Target Review

The FDA’s new roadmap In April 2025, the FDA announced a major regulatory shift with its plan to phase out the requirement for animal testing in the development of monoclonal antibodies and other drugs, when scientifically appropriate. NIH Office of Laboratory Animal Welfare – Training Guidelines. Bailey J, et al.

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A global push for better animal welfare in research

Drug Target Review

Complex challenges in reducing animal use One of the most pressing issues Liz highlights is the misconception that animal testing can be eliminated entirely in the near future. Microphysiological systems and other non-animal models are incredibly promising, but they’re not a total replacement,” she cautions.

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Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

This also has clear potential to reduce animal testing, another key commitment made by the Commission. The Omnibus Regulation has four main articles reattributing responsibilities across the four EU agencies primarily concerned with chemical regulation. Article 3 redirects tasks to ECHA regarding medical devices.