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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

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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Closing the translation gap in oncology drug development

Drug Discovery World

Jantzen Sperry , PhD, Director of Scientific Operations at Certis Oncology looks at how the adoption of orthotopic PDX models can elevate the impact of cancer research and improve translation in oncology drug development. Mice have long been heroes of preclinical cancer research. Cancer is far more complex than the sum of its parts.

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Exploring alternatives to animal testing in drug discovery

Drug Target Review

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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What does the FDA animal testing legislation mean for drug discovery? 

Drug Discovery World

ends a federal mandate that experimental drugs need to be tested on animals before they can be used in human clinical trials 2. As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. The Modernization Act 2.0

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FDA Modernization Act 2.0: A step in the right direction

Drug Discovery World

Products and technologies such as cell-based assays, microphysiological systems and computer modelling will now all be regarded as suitable alternatives to animal testing in the early phases of drug development. A paper published in the American Journal of Translational Research explains the issue well. “In

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