FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools
Executive Summary
Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.
You may also be interested in...
Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.
Drug Manufacturers Beg US FDA To Inspect Facilities, But Still Find Difficulties
As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.