Non-animal testing methods could save drugmakers time and money, officials say ...
The U.S. Food and Drug Administration is actively steering drug developers away from traditional animal studies and toward human-biology-based testing methods for monoclonal antibody programs. The ...
On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s ...