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 ...
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
The FDA has released draft guidance that aims to clear up how drug developers can use alternative testing – but that doesn’t mean animal testing in the US is over.
March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce ...
Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency is recalibrating its evidentiary standards to align wit ...
A team of researchers from Drexel University has developed an innovative approach to rigorously test and improve the robustness of autonomous driving systems. Their study, presented this summer at ...
In this chapter, we focus on two topics: the lack of enforcement of existing U.S. Department of Defense (DOD) guidelines and procedures and the role of the program manager in the acquisition process.
The cannabis market is rapidly growing as legalization continues to increase across the United States and Internationally. As a result, an influx of different types of cannabis infused edibles and ...
In this and the next four chapters, the panel assesses the industry practices described at the workshop and discusses their applicability within defense acquisitions. As noted in Chapter 1, a number ...