Animal Testing, Biosimilars and Pharmacokinetics

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Animal Testing

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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

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. §

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

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

The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. 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.

FDA

FDA Animal Testing Pharmacokinetics Small Molecule

Drug Discovery Digest

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

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

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