FDA and NIH announce actions to advance alternative research methods and validation frameworks.
The U.S. Food and Drug Administration (FDA) recently released a draft guidance outlining how drug developers can implement new approach methodologies (NAMs) as alternatives to animal testing in nonclinical studies. The guidance from the Center for Drug Evaluation and Research (CDER) outlined principles for demonstrating reliability, human biological relevance, technical rigor, and fitness for regulatory use when sponsors submit data to support drug applications.
“It is time for the FDA to shift the drug development paradigm away from the current default of using animals to predict human responses to one where these data are obtained through human-centric models which can more reliably, efficiently and ethically predict human drug reactions prior to clinical trials,” said Acting Drug Evaluation and Research Director Tracy Beth Hoeg.
The National Institutes of Health (NIH) also announced more than $150 million to expand research using human-focused research through the Complement-ARIE program, to reduce reliance on animal models. The initiative will fund technology development centers, a data-sharing hub, and a validation network intended to standardize methods and prepare them for regulatory review. Pilot projects will study areas such as neurological conditions, cardiac disease, and toxicity testing, with collaboration involving the FDA and Environmental Protection Agency.
As the Lord Leads, Pray with Us…
- For Commissioner Marty Makary and Administrator Bhattacharya as they oversee changes affecting drug development and research standards.
- For officials in the FDA and the NIH as they evaluate new scientific methods with care, transparency, and accountability.
- For researchers, patients, and developers to proceed with scientific integrity, patient safety, and ethical considerations as they develop new testing models.
Sources: Food and Drug Administration, National Institute of Health
