James R. Johnson
Hogan Lovells
Articles
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…
In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn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…
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…
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…
