FDA's First 90-Day Letters To Deliver Inspection Outcomes After Jan. 1
Happy New Year – or not! Firms inspected by US FDA since Oct. 1 will receive word within 90 days whether their facilities received passing – or failing – grades under timelines mandated by GDUFA II and incorporated into the agency's new Concept of Operations agreement, FDA officials tell FDLI meeting.
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US FDA is issuing “90-day” decisional letters at a quickening pace, publishing the inspectional results within another 30 days, and copying sponsors on warning letters, among other steps, to call their attention to GMP problems in their supply chains.
US agency's Office of Pharmaceutical Quality continues to accelerate review and inspection processes, according to its first annual report. Meanwhile, the office's signature quality metrics initiative goes underground.
'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.