Search Results for keywords:"Model-Informed Drug Development"

The Food and Drug Administration (FDA) is hosting a workshop titled "Best Practices for Development and Application of Disease Progression Models," which is part of their performance commitment under the Prescription Drug User Fee Act of 2017. The workshop aims to discuss the best practices for creating disease progression models that can aid in drug development, and to explore current challenges and research needs in this area. The FDA is inviting the public to submit comments about areas of interest related to disease progression modeling to ensure a comprehensive discussion during the workshop. Comments must be submitted by March 26, 2021, and can be sent electronically or through written/paper submissions.

The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development."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.