Animal Testing, Biosimilars and DNA - Drug Discovery Digest

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Animal Testing

Biosimilars

DNA

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.

Drug Development

Drug Development Clinical Supply Production 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

Rapid delivery of toxicological material

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

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