Opinion: FDA should use its existing program to qualify new tools for drug safety testing
The field of toxicology — determining whether a product is safe or harmful — is evolving rapidly. Many innovative drug safety technologies based on human biology, rather than the biology of other animals, are available for assessing whether potential medicines are likely to be safe or toxic in humans. Unfortunately, many of these new methods have yet to influence the FDA’s decision-making, even though it has a program in place that could be adapted to include human-based methods for nonclinical assessment.
Every March, thousands of toxicologists from around the world gather for the Society of Toxicology’s annual meeting. Animal-based approaches once held the spotlight. But these days, the exposition hall is filled with companies showcasing innovative methods that incorporate human biology to predict whether a product is likely to be safe or harmful for humans. Presentations, posters, and training in these new approaches are also abundant.
