Search Results for keywords:"International Council for Harmonisation"

The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development."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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance titled "E6(R3) Good Clinical Practice: Annex 2." This document was developed with the International Council for Harmonisation (ICH) and provides guidance for conducting clinical trials with decentralized and pragmatic elements, while using real-world data. The aim is to encourage innovative trial designs and to focus on critical aspects that affect participant safety and data reliability. Comments on the draft can be submitted until February 28, 2025, before the final version is prepared.

The Food and Drug Administration (FDA) announced the release of final guidance titled "E11A Pediatric Extrapolation," prepared with the International Council for Harmonisation. This guidance aims to streamline pediatric drug development, focusing on strategies like safety extrapolation and statistical methodologies to ensure safe, effective medicines for children. It replaces a draft guidance from August 2022 and includes updates to study designs and modeling approaches. The public can comment on this guidance, which is accessible through FDA's regulations website.