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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