The initiatives underway at FDA’s Center for Drug Evaluation and Research (CDER) that its new Office of Pharmaceutical Quality (OPQ) will help drive include expertise-based team reviews, closer review/inspection alignment, an auditable quality management system (QMS), a comprehensive pharmaceutical quality IT platform, and new preapproval and surveillance inspection approaches.
In mid-October, CDER Director Janet Woodcock announced that the CDER restructuring she has been spearheading, including the establishment of OPQ, has been finalized and will become effective in early January 2015.
OPQ will be a “super-office” reporting directing to her, with eight quality-related offices underneath it (see IPQ’s October 25, 2014 companion story for a list of the offices, their leadership, and basic functions). Woodcock will initially serve as acting director, and Lawrence Yu, who has been acting director of the Office of Pharmaceutical Science (OPS), will become OPQ’s deputy director.
The CDER restructuring is emblematic of the effort FDA is making to: ● more coherently assess a company’s quality management abilities ● understand better where the patient risks and protections lie within particular operations and across the global manufacturing and supply chain spectrum, and ● be more effective in using its regulatory suasion to help industry evolve from a compliance to a quality culture-oriented mindset.
[CLICK HERE for the complete story. Included are insights from Woodcock and Global Regulatory Operations and Policy (GO) Deputy Commissioner Howard Sklamberg on the CDER quality initiatives and how they relate to the changes underway across FDA to better align its center and field processes on a commodity program basis. Nonsubscribers can get information on IPQ subscription/licensing and individual story purchasing by contacting Peter Blachly (Peter@ipq.org)]