The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development." This document was created under the International Council for Harmonisation (ICH) and provides recommendations on planning, evaluating, and documenting evidence in drug development using models. It aims to help harmonize regulations globally, enhancing drug development and improving manufacturing standards. Public comments on the draft can be submitted until February 28, 2025.
Simple Explanation
The FDA wrote a guide to help scientists use special models when making new medicines, so everyone around the world can agree on the best ways to do this. People can share their thoughts about it until February 2025, but the guide might be a little tricky to understand because it uses big words and doesn't always explain what they mean.