ARTICLE SUMMARY:
The US agency criticized the Global Harmonization Working Party for diluting the perspective of regulators and modifying documents from other organizations in its November 17 decision to withdraw from the group. FDA says it will devote all of its harmonization efforts to IMDRF, which it will be chairing in 2024.
FDA withdrew its membership in the Global Harmonization Working Party (GHWP) after concluding the group “does not offer the opportunity for FDA and other regulatory bodies to have our voices heard and considered.”
