US FDA Getting Faster At Notifying Drug Facility Owners Of Inspection Status
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.
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The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.
Tens of thousands of listed drugs could be barred if manufacturers do not update their records.
'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.