Citing increasingly divergent harmonization efforts for medical devices, the U.S. Food and Drug Administration (FDA) has announced its withdrawal from the Global Harmonization Working Party (GHWP). The FDA formally notified the GHWP of its decision in a letter to Jinghe Xu, Chair of the GHWP, sent in late November. The letter, signed by Jeffrey Shuren, … Continue reading FDA Withdraws from Global Harmonization Working Party