FDA Quality Office Looks Back At 2017: Reviews Accelerated, Inspections Realigned

02 Mar 2018

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.

The US FDA's Office of Pharmaceutical Quality made advances last year in strengthening and accelerating quality assessments of new and generic drugs, biosimilars and biologics, the office said Feb. 28 in its first annual report.

The office also played a key role last year in reshaping and strengthening the agency's process for inspecting drug manufacturing...