FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animal testing not eliminate animal testing in drug development. adequate to justify the proposed clinical testing.” The pre-existing statutory language did not require animal testing.

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Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Target Review

JULY 7, 2025

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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Drug Research Research Animal Testing Drugs 52

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

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Animal Testing Drugs Clinical Trials Clinical Research 105