Opinion: FDA should use its existing program to qualify new tools for drug safety testing
Integrating into FDA applications qualified drug safety tests based on human biology will mean safer drugs, financial savings, less animal testing, and better medicines.
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
