Animal Testing, Biosimilars and DNA - Drug Discovery Digest

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

To achieve an aggressive timeline from DNA to investigational new drug (IND) application, drug developers have strengthened collaborations with contract development & manufacturing organisations (CDMOs) to expedite drug development. FDA no longer has to require animal testing for new drugs. References: 1 Wadman M.

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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.

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Drug Discovery Digest

Rapid delivery of toxicological material

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

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