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FDA’s New Office of Program and Regulatory Operations Will Assume Pivotal Role in CMC Review

Nov 15th, 2014

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FDA’s Office of Program and Regulatory Operations (OPRO) – part of the new Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER) – will be responsible for co-leading and facilitating the review of the quality portions of new and abbreviated new drug applications (NDAs/ANDAs).

OPRO will also have responsibility for: ● providing expert regulatory knowledge to the review teams ● designing and implementing a quality management system (QMS) across OPQ, and ● facilitating the learning and professional development of OPQ staff.

As such, OPRO will play a pivotal role in supporting OPQ’s mission of pulling together all quality-related functions into one “super office” to help transform CDER’s quality regulatory processes.

The structure and function of OPQ have been taking more concrete shape over the past few months, and CDER Director Janet Woodcock and other senior management have been shedding light on OPQ’s significance and further implementation plans at recent public meetings [IPQ October 25 and October 26].

At the GPhA/FDA Fall Technical Conference held in late October in Bethesda, Maryland, Robert Gaines, who will head OPRO’s Division of Program and Regulatory Operations II, discussed the four facets of his office’s mission and highlighted the cross-office nature of its activities.

Gaines concluded his talk with valuable advice on what applicants need to do to facilitate reviews within the new OPQ structure.

[The story continues for subscribers beginning on page 2.  Nonsubscribers can get information on IPQ subscription/licensing and individual story purchasing by contacting Wayne Rhodes ([email protected])].

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