Day: March 12, 2020

Research INDs, sponsored mostly by academic centers, are exempt from electronic submission and, hence, are mostly filed in traditional paper format. FDA now wants even those INDs to follow the Common Technical Document (CTD) format and submit electronically via the Electronic Submission Gateway (ESG) but would exempt them from the electronic CTD requirements, namely the … Read more

FDA announced this week that it is cancelling all scheduled foreign inspections and limit domestic travel only to mission critical functions essentially stopping all inspection activities to address the spread of coronavirus infection. This is an extension of last week’s announcement where FDA cancelled all inspections in China. During this time, FDA would rely on … Read more