FDA Quality Office Looks Back At 2017: Reviews Accelerated, Inspections Realigned
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.
You may also be interested in...
FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals
FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II.
US FDA Quality Metrics Initiative Continues Moving Forward … Quietly
Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.
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.