NEWS, REPORTS & POSITION STATEMENTS 1. ICH S7A revised after 25 Years: Why it matters for NAMs developers The International Council for Harmonisation (ICH) S7A guideline on safety pharmacology studies, finalized in 2000, has been pivotal in protecting clinical trial […]
NEWS, REPORTS & POSITION STATEMENTS 1. Novo Nordisk principal scientist highlights the urgency of advancing human-relevant 3D tissue models As regulatory momentum accelerates globally to reduce reliance on animal testing, leading experts in microphysiological systems (MPS), complex in vitro models […]
NEWS, REPORTS & POSITION STATEMENTS 1. UK: MHRA published guidance on its approach to medicines developed using non-animal methods The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medicines, medical devices and blood components for transfusion in […]
NEWS, REPORTS & POSITION STATEMENTS 1. FDA: General considerations for the use of NAMs in drug development The Food and Drug Administration (FDA) announced the availability of a draft guidance for industry. The purpose of this draft guidance is to […]
NEWS, REPORTS & POSITION STATEMENTS 1. Agentic AI and the rise of in silico team science in biomedical research Agentic artificial intelligence (AI) systems are emerging as teams of intelligent computational experts capable of rivaling human performance in labor-intensive tasks, […]