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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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The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models. In this blog post, we examine several alternative approaches to animal testing and how the FDA handles the application of these methods in specific scenarios.

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