President Biden of the United States of America recently signed into law the omnibus spending bill, which incorporated the FDA Modernization Act 2.0. This Act requires the FDA to consider alternatives to animal testing by amending the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act (PHSA), which applies to biosimilar drugs. This session will explore the potential advantages of the Modernization Act, including:
- Accelerating drug development and lowering costs by using alternatives to animal models
- Reducing or waiving animal testing requirements by leveraging in vitro, in silico and in chemico tests
- Expanding flexibility already associated with the 505(b)(2) New Drug Application (NDA) process and creating a speedier path to market for 505(b)(1) NDAs and biosimilars
- Identifying applications of in silico models in the clinical setting to streamline programs
William Salminen, Vice President, Nonclinical Safety and Toxicology, Premier Consulting
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