Regulatory Blog

The FDA has released two important guidances addressing very different but equally critical domains of drug development: the " nonclinical safety evaluation of monospecific monoclonal antibodies " and the appropriate inclusion of " QTc Information in Human Prescription Drug and Biological Product Labeling " . While one guidance focuses on modernising preclinical toxicology expectations for biologics, the other ensures that cardiac electrophysiology risks are clearly and consi

This USFDA draft guidance" Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutic s" , issued on 15 November 2024, offers...