18 Mars 2026 The purpose of FDA's draft guidance is to provide drug developers with a validation framework of alternatives to animal testing for nonclinical safety, here referred to as new approach methologies (NAM), such as in vitro and in silico methods. The document emphasises that a NAM does not need to be formally validated before FDA’s drug review centres (primarily the Center for Drug Evaluation and Research) can evaluate it as part of a drug development programme. In