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FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience

USA - August 23 2021 Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to…

Daniel J. Roberts, Stephanie Slater, Lowell Zeta

In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

USA - June 1 2021 On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug…

Robert Church, David Horowitz, Philip Katz

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

USA - April 15 2021 On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug…

Robert Church, Christopher Fanelli, Matthew Johnson, Scott Kaplan, Daniel J. Roberts, Lowell Zeta

Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight

USA - January 28 2021 The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast…

Christopher Fanelli, Daniel J. Roberts

China’s drug regulator seeks comments on updated drug recalls regulation

China - October 14 2020 On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products…

Xin Tao