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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

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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. An observatory will also be created that publicly compiles information on the properties, uses, and market presence of certain chemicals. This observatory will initially focus on nanomaterials.

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Origins of the Lab Mouse

Codon

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market. Nature (2002). Credit: Hedges S.B.