The FDA’s emerging framework represents more than a regulatory update; it is a paradigm shift toward human-relevant, ...
In April 2025, the U.S. Food and Drug Administration (FDA) released its Roadmap to Reducing Animal Testing in Preclinical Safety Studies—a landmark initiative that lays out a plan to make animal ...
Automation, miniaturization, and new software algorithms are improving throughput and accuracy. High-throughput screening (HTS) enables the rapid testing of numerous compounds against biological ...
A rare moment of bipartisan progress has emerged with the Senate’s unanimous passage of the FDA Modernization Act 3.0, ...
The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal antibodies and some other drug candidates. Animal testing will be "reduced, ...
Although it is sometimes thought that quality assurance (QA) and software testing are the same, they are, in fact, different concepts. They differ in their objectives, features and methods. Testers ...