1. Pink Sheet

US FDA Getting Faster At Notifying Drug Facility Owners Of Inspection Status

 
• By Sue Sutter

Agency issued final classification determinations within 90 days after an inspection 86% of the time in fiscal year 2019 and continues to reduce the time interval for sending GMP warning letters, CDER compliance director Donald Ashley tells FDLI conference.

regulatory compliance concept on the gearwheels, 3D rendering
Facility owners are learning their inspection compliance status earlier from the US FDA. • Source: Shutterstock

The US Food and Drug Administration’s faster turnaround of facility classification decisions is providing greater transparency for drug sponsors into the inspectional status of their contract manufacturers, Center for Drug Evaluation and Research compliance office director Donald Ashley said.

In fiscal year 2019, CDER notified the facility owner of its classification status within 90 days after an inspection 86%...

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