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
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
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
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 - 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